REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
FDA 510(k) clearance K894299 · decided 1989-09-22
Clearance details
- K-number
- K894299
- Device name
- REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
- Applicant
- Repro-Med Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-22
- Decision date
- 1989-09-22
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- BSY
- Device class
- 1
- Regulation number
- 868.6810
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Middletown, NY, US
- Third-party review
- No
- Expedited review
- No
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| TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707) | Sorenson Critical Care | 1997-03-11 |
| TRACH CARE SET WITH MICROBAN (K964369) | Ballard Medical Products | 1997-02-11 |
| NEO 2 LINE SUCTION SYSTEM (K960488) | Alcove Medical, Inc. | 1996-04-26 |
| ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (K955831) | Sherwood Medical Co. | 1996-03-28 |
| CATH-GUIDE (K955645) | Hudson Respiratory Care, Inc. | 1996-03-12 |
| REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (K952396) | Contour Fabricators of Florida, Inc. | 1995-08-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| REPRO-MED - THD (P820034/S005) | Repro-Med Systems, Inc. | 1997-01-14 |
| REPRO-MED - THD (P820034/S004) | Repro-Med Systems, Inc. | 1993-04-29 |
| REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY (P820034/S003) | Repro-Med Systems, Inc. | 1993-04-28 |
| REPRO-MED - THD (P820034/S002) | Repro-Med Systems, Inc. | 1987-05-12 |
| REPRO-MED - THD (P820034/S001) | Repro-Med Systems, Inc. | 1985-01-31 |
| REPRO-MED - THD (P820034) | Repro-Med Systems, Inc. | 1984-12-26 |