FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPTER, C/D SUCTION
K Number: K781713
·
Decision Dec 12, 1978
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
45
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADAPTER, C/D SUCTION
- K Number
- K781713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Novametrix Medical Systems, Inc.
- Date Received
- October 6, 1978
- Decision Date
- December 12, 1978
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTR), ordered by most recent decision date.
Spiro-VISTA
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
FDA 510(k)
FDA Class 2
·Anesthesiology
AeroJet Ventilation Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
FDA 510(k)
FDA Class 2
·Anesthesiology
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Novametrix Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | Apr 25, 2001 | Substantially Equivalent |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | Apr 10, 2000 | Substantially Equivalent |
| K993979 | MARSPO2, MODEL 2001 | Feb 22, 2000 | Substantially Equivalent |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | Oct 16, 1998 | Substantially Equivalent |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | Apr 4, 1997 | Substantially Equivalent |
| K963380 | CO 2 SMO PLUS | Jan 22, 1997 | Substantially Equivalent |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | Nov 20, 1996 | Substantially Equivalent |
| K960831 | VENTRAK RMMS 1550 | May 29, 1996 | Substantially Equivalent |
| K924626 | NOVAMETRIX MODEL 510 | Dec 3, 1993 | Substantially Equivalent |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | Jul 15, 1992 | Substantially Equivalent |