FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXY-OFF(TM)
K Number: K863510
·
Decision Oct 22, 1986
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
6
Applicant Total
23
Review Days
43
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
- OXY-OFF(TM)
- K Number
- K863510
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2350
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- B&B Medical Technologies, Inc.
- Date Received
- September 9, 1986
- Decision Date
- October 22, 1986
- Product Code
- BXY
- 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 |
|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXY), ordered by most recent decision date.
WESTMED RESPIRATORY LUER ADAPTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
PRECISION MEDICAL NEB BLOCK
FDA 510(k)
FDA Class 1
·Anesthesiology
PRECISION MEDICAL ELIMINATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
LSP MINILATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
FDA 510(k)
FDA Class 1
·Anesthesiology
PFT GASES
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by B&B Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030396 | OMNI~NEB; OMNI~MAX | May 7, 2004 | Substantially Equivalent |
| K980407 | HOPE NEBULIZER | May 27, 1998 | Substantially Equivalent |
| K960663 | UNIVERSAL BITE BLOCK | May 17, 1996 | Substantially Equivalent |
| K945816 | QUICK-LOCK | Jan 13, 1995 | Substantially Equivalent |
| K944324 | SURE-LOCK VENTILATOR TUBING HOLDER | Nov 4, 1994 | Substantially Equivalent |
| K935171 | STABILTRACH | Dec 2, 1993 | Substantially Equivalent |
| K925386 | ADHESIVE E.T. TAPE | Apr 19, 1993 | Unknown |
| K923690 | MINI HEART | Oct 20, 1992 | Substantially Equivalent |
| K913015 | HEART NEBULIZER FLOWMETER ADAPTOR | Nov 20, 1991 | Substantially Equivalent |
| K913753 | BODAI NEO2 -SAFE AIRWAY PRESSURE CAP | Oct 23, 1991 | Substantially Equivalent |