FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-CONDUCTIVE ANESTHESIA FACE MASK
K Number: K803185
·
Decision Jan 5, 1981
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
632
Review Days
20
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
- NON-CONDUCTIVE ANESTHESIA FACE MASK
- K Number
- K803185
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- December 16, 1980
- Decision Date
- January 5, 1981
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSJ), ordered by most recent decision date.
SuperNO2VA Device
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE ADHESIVE FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic
| K Number | Device Name | ||
|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 | Substantially Equivalent |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Mar 21, 2001 | Substantially Equivalent |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | Feb 1, 2001 | Substantially Equivalent |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | Nov 29, 2000 | Substantially Equivalent |
| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 25, 2000 | Substantially Equivalent |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |