SCM-3 AND ACCESSORIES
FDA 510(k) clearance K914921 · decided 1992-03-12
Clearance details
- K-number
- K914921
- Device name
- SCM-3 AND ACCESSORIES
- Applicant
- Gaymar Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-04
- Decision date
- 1992-03-12
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- IKY
- Device class
- 1
- Regulation number
- 880.5150
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Orchard Park, NY, 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 |
|---|---|---|
| GEL FLOTATION MATTRESS (K813226) | Jefferson Industries, Inc. | 1981-12-02 |
| TETRA NATAL-MAT WATER FLOTATION MAT. (K802833) | Tetra Group U.S.A., Inc. | 1980-12-10 |
| BEDDING PADS EGGCREATE PADS (K802781) | Leemart Bedding Mfg. Co. | 1980-12-10 |
| ECONO-FLOAT WATER FLOTATION MATTRESS (K780779) | Jefferson Industries, Inc. | 1978-05-19 |
| NEONATAL FLOTATION SYSTEM (K772062) | Medpro, Inc. | 1977-11-15 |
| MEDPRO FLOTATION SYSTEM (K771824) | Medpro, Inc. | 1977-10-19 |
| DECUBITUS MATTRESS (K760963) | Arco Medical Products Co. | 1976-11-18 |
Recalls involving this device
No recalls on record reference this clearance.