FIRST AID KIT(S)
FDA 510(k) clearance K963298 · decided 1996-11-06
Clearance details
- K-number
- K963298
- Device name
- FIRST AID KIT(S)
- Applicant
- Vector, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-21
- Decision date
- 1996-11-06
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- BYG
- Device class
- 1
- Regulation number
- 868.5580
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orchard Park, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HANS RUDOLPH NASAL CPAP MASK (K962848) | Hans Rudolph, Inc. | 1996-10-16 |
| DISPOSABLE, CPAP OXYGEN MASK (K945482) | Fvtnks | 1995-09-19 |
| WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (K953464) | Westmed, Inc. | 1995-09-18 |
| VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (K953039) | Dadsun Corp., Ltd. | 1995-09-15 |
| WESTMED PEDIATRIC AND ADULT AEROSOL MASK (K945472) | Westmed Intl. | 1995-02-07 |
| JEMSDAL MASK (K942907) | Respan Products, Inc. | 1994-08-31 |
| SYSTEM 22 ADULT MASK (K940887) | Medic-Aid , Ltd. | 1994-04-19 |
| SYSTEM 22 PAEDIATRIC MASK (K940888) | Medic-Aid , Ltd. | 1994-04-19 |
| MEDWAY OXYGEN MASK (K931952) | Medway | 1993-08-20 |
| SURGICO OXYGEN MASK (K924069) | Gujarat Surgico, Ltd. | 1993-02-04 |
| SEAL RING FOR NASAL CPAP (K921499) | Devilbiss Health Care, Inc. | 1992-09-17 |
| TRACHEOSTOMY MASK (K913501) | B & F Medical Products, Inc. | 1992-01-13 |
Recalls involving this device
No recalls on record reference this clearance.