THE AIRCEL SYSTEM
FDA 510(k) clearance K954593 · decided 1996-02-06
Clearance details
- K-number
- K954593
- Device name
- THE AIRCEL SYSTEM
- Applicant
- Marcon Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-03
- Decision date
- 1996-02-06
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- FNM
- Device class
- 2
- Regulation number
- 880.5550
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, 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 |
|---|---|---|
| PRESSURE GUARD SITE SELECT (A) (K973169) | Span-America Medical Systems, Inc. | 1998-02-20 |
| ZAK-2000 (K972022) | Cardio Systems, Inc. | 1998-01-22 |
| MIGHTY AIR (K974319) | Wheelchairs of Kansas | 1998-01-22 |
| PHYSIO/1000 (K974070) | Physio Designs, Inc. | 1998-01-06 |
| SIMPULSE (K972549) | Kinetic Concepts, Inc. | 1997-11-18 |
| SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (K970081) | Cathay Consolidated, Inc. | 1997-11-07 |
| BARIAIR (K955243) | Kinetic Concepts, Inc. | 1997-10-23 |
| KT AIR BED (K970468) | Kinetic Concepts, Inc. | 1997-09-05 |
| RID-DECUBE II (K965207) | Skin Care Management, Inc. | 1997-08-21 |
| ALTERNATING PRESSURE AIR FLOTATION MATTRESS (K972153) | Decubiti Concepts, Inc. | 1997-07-31 |
| REST MATTRESS (K971568) | Rest Mattress | 1997-07-18 |
| MODIFIED PEDIKAIR (K954320) | Kinetic Concepts, Inc. | 1997-07-18 |
Recalls involving this device
No recalls on record reference this clearance.