510(k) K834535
- Device
- Nitrous Oxide Recycler
- Applicant
- G & L UNLTD.
- 510(k) number
- K834535
- Product code
- BSF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-07
- Date received
- 1983-12-22
- Regulation
- 868.5310
- Classification name
- Absorber, Carbon-Dioxide
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3010131137
- 9616692
- 3005855942
- 3002807267
- 3045058049
- 3010187802
- 3005367964
- 2112667
- 3016904853
- 3012494290
- 3002807637
- 2022648
- 3013557562
- 9710602
- 1066427
- 3009694883
- 3014579161
- 3010601984
- 3020614
- 3034669683
- 8010042
- 3030446844
- 9611500
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BSF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951093 | KAB SYSTEM | King Systems Corp. | 1995-03-24 |
| K852071 | OHMEDA GMS ABOSORBER | Ohmeda Medical | 1985-07-15 |
| K843422 | OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR | Ohmeda Medical | 1984-10-23 |
| K833452 | OHIO GMS ABSORBER | Airco/Ohio Medical Products | 1983-11-29 |
| K821144 | OHIO ABSORBER | Ohio Medical Products | 1982-05-28 |
| K801255 | PENLON JUMBO CARBON DIOXIDE ABSORBER | Penlon, Inc. | 1980-06-04 |
| K760076 | ABSORBER, ANESTHESIA CIRCLE SYS, CO2 | Fraser Sweatman, Inc. | 1976-07-16 |