FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN MASKS 81420, 81421, 81471 & 81461
K Number: K913383
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
54
Applicant Total
11
Review Days
81
Basic Information
- Device Name
- OXYGEN MASKS 81420, 81421, 81471 & 81461
- K Number
- K913383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SPECIALTY PACKAGING PRODUCS, INC.
- Date Received
- July 29, 1991
- Decision Date
- October 18, 1991
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
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Other Clearances by SPECIALTY PACKAGING PRODUCS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | Aug 24, 1992 | Substantially Equivalent |
| K913163 | NON REBREATHING VALVE | Feb 3, 1992 | Substantially Equivalent |
| K913422 | OXYGEN TUBING, 81503 | Jan 30, 1992 | Substantially Equivalent |
| K913164 | NON REBREATHING MASK | Jan 15, 1992 | Substantially Equivalent |
| K913216 | TRACH T ADAPTER | Jan 15, 1992 | Substantially Equivalent |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Oct 18, 1991 | Substantially Equivalent |
| K913220 | AEROSOL MASKS, 81426, 81476, 81490 & 81492 | Oct 10, 1991 | Substantially Equivalent |
| K913275 | VENTURI OXYGEN MASK | Oct 10, 1991 | Substantially Equivalent |
| K913455 | OXYGEN MASKS 82400 & 82405 | Oct 2, 1991 | Substantially Equivalent |
| K910896 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT | May 8, 1991 | Substantially Equivalent |