FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CANNULA NASAL OXYGEN
K Number: K920573
·
Decision Aug 11, 1992
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
18
Review Days
186
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
- CANNULA NASAL OXYGEN
- K Number
- K920573
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- B & F Medical Products, Inc.
- Date Received
- February 7, 1992
- Decision Date
- August 11, 1992
- Product Code
- CAT
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
4 SURE TM NASAL OXYGEN CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 467
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by B & F Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | Jul 27, 1994 | Substantially Equivalent |
| K913501 | TRACHEOSTOMY MASK | Jan 13, 1992 | Substantially Equivalent |
| K861325 | MAXI-USE O2 DEVICE | Sep 9, 1986 | Substantially Equivalent |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | Apr 9, 1986 | Substantially Equivalent |
| K853004 | PORTABLE OXYGEN UNIT | Aug 29, 1985 | Substantially Equivalent |
| K843691 | PORTABLE OXYGEN UNIT | Nov 7, 1984 | Substantially Equivalent |
| K823532 | STOCK #64091-PEDIATRIC OXYGEN MASK | Jan 5, 1983 | Substantially Equivalent |
| K811404 | TRAVELAIRE | Jun 9, 1981 | Substantially Equivalent |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | Dec 22, 1980 | Substantially Equivalent |
| K802646 | HAND PERCUSSOR CUP #65210 | Nov 12, 1980 | Substantially Equivalent |