BSF · Absorber, Carbon-Dioxide
Anesthesiology · 21 CFR 868.5310 · Class 1
Overview
| Product Code | BSF |
|---|---|
| Device Name | Absorber, Carbon-Dioxide |
| Regulation | 21 CFR 868.5310 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951093 | KAB SYSTEM | King Systems Corp. | Mar 24, 1995 | SESE |
| K852071 | OHMEDA GMS ABOSORBER | Ohmeda Medical | Jul 15, 1985 | SESE |
| K843422 | OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR | Ohmeda Medical | Oct 23, 1984 | SESE |
| K834535 | NITROUS OXIDE RECYCLER | G & L Unltd. | Jun 7, 1984 | SESE |
| K833452 | OHIO GMS ABSORBER | Airco/Ohio Medical Products | Nov 29, 1983 | SESE |
| K821144 | OHIO ABSORBER | Ohio Medical Products | May 28, 1982 | SESE |
| K801255 | PENLON JUMBO CARBON DIOXIDE ABSORBER | Penlon, Inc. | Jun 4, 1980 | SESE |
| K760076 | ABSORBER, ANESTHESIA CIRCLE SYS, CO2 | Fraser Sweatman, Inc. | Jul 16, 1976 | SESE |
Top Applicants
- Ohmeda Medical — 2 clearances
- Penlon, Inc. — 1 clearance
- Ohio Medical Products — 1 clearance
- King Systems Corp. — 1 clearance
- G & L Unltd. — 1 clearance
