NITROUS OXIDE RECYCLER
FDA 510(k) clearance K834535 · decided 1984-06-07
Clearance details
- K-number
- K834535
- Device name
- NITROUS OXIDE RECYCLER
- Applicant
- G & L Unltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-22
- Decision date
- 1984-06-07
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- BSF
- Device class
- 1
- Regulation number
- 868.5310
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, 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 |
|---|---|---|
| KAB SYSTEM (K951093) | King Systems Corp. | 1995-03-24 |
| OHMEDA GMS ABOSORBER (K852071) | Ohmeda Medical | 1985-07-15 |
| OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR (K843422) | Ohmeda Medical | 1984-10-23 |
| OHIO GMS ABSORBER (K833452) | Airco/Ohio Medical Products | 1983-11-29 |
| OHIO ABSORBER (K821144) | Ohio Medical Products | 1982-05-28 |
| PENLON JUMBO CARBON DIOXIDE ABSORBER (K801255) | Penlon, Inc. | 1980-06-04 |
| ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (K760076) | Fraser Sweatman, Inc. | 1976-07-16 |
Recalls involving this device
No recalls on record reference this clearance.