CONTINUOUS VENTILATOR
FDA 510(k) clearance K844809 · decided 1985-06-27
Clearance details
- K-number
- K844809
- Device name
- CONTINUOUS VENTILATOR
- Applicant
- Hamilton Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-27
- Decision date
- 1985-06-27
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- GBX
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Reno, NV, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704) | Dmc Medical, Ltd. | 2000-05-19 |
| LYSONIX IRRIGATION SYSTEM (K974233) | Lysonix, Inc. | 1998-02-03 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146) | Axiom Medical, Inc. | 1997-03-10 |
| SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295) | Sil-Med Corp. | 1996-06-26 |
| CLOSED FLUID COLLECTION SYSTEM (K961147) | B.Braun Medical, Inc. | 1996-05-31 |
Recalls involving this device
No recalls on record reference this clearance.