COMBO 36
FDA 510(k) clearance K854257 · decided 1985-11-18
Clearance details
- K-number
- K854257
- Device name
- COMBO 36
- Applicant
- Kg Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-22
- Decision date
- 1985-11-18
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- FNJ
- Device class
- 1
- Regulation number
- 880.5120
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Woonsocket, RI, 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 |
|---|---|---|
| KING KRIB (K934298) | Noritage, Inc. | 1994-01-26 |
| CRADLE, HOSPITAL BED CLOTHING (K892877) | Warsaw Orthopedic, Inc. | 1989-06-15 |
| BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (K885241) | King Mfg. Co. | 1989-02-24 |
| SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (K884542) | Commercial Products & Engineering Co. | 1988-11-21 |
| ENVIROTENT (BED) (K881725) | Envirotents, Inc. | 1988-11-08 |
| MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (K881961) | Med Service, Inc. | 1988-11-01 |
| MSI 3003 SERIES BED (K881964) | Med Service, Inc. | 1988-06-28 |
| MSI 2005 SERIES BED (K881962) | Med Service, Inc. | 1988-06-03 |
| FOLDING HOSPITAL COT NSN 6530-00-299-8517 (K881043) | Junkin Safety Appliance Co., Inc. | 1988-04-12 |
| PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (K870166) | George C. Kuhn | 1987-03-13 |
| VSID MEDICAL THREE-FOLDING BED (K870310) | China National Medicines & Health Prod. I/E Corp. | 1987-02-10 |
| PENOX HOSPITAL BED (K864667) | Penox Technologies, Inc. | 1987-01-21 |
Recalls involving this device
No recalls on record reference this clearance.