STERI-VAC(TM) AERATOR MODEL XL
FDA 510(k) clearance K904921 · decided 1990-12-05
Clearance details
- K-number
- K904921
- Device name
- STERI-VAC(TM) AERATOR MODEL XL
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-31
- Decision date
- 1990-12-05
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FLI
- Device class
- 2
- Regulation number
- 880.6100
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, 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 |
|---|---|---|
| GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR (K902906) | Gas-Vak | 1990-10-15 |
| CASTLE MODEL 3341 & 3441 & 4141 GAS AER (K831595) | Castle Co. | 1983-06-15 |
| BEAR JET 150 VENTILATOR (K830165) | Bear Medical Systems, Inc. | 1983-04-12 |
| CASTLE #3241 GAS AERATOR (K813201) | Sybron Corp. | 1981-12-31 |
| EO EVACUATING SYSTEM I (K790677) | Castle Co. | 1979-05-07 |
| CASTLE MODEL 3146 GAS AERATOR (K781484) | Castle Co. | 1978-10-27 |
| PORTAGAS AERATOR (K761341) | Amsco Co. | 1977-02-28 |
Recalls involving this device
No recalls on record reference this clearance.