CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
FDA 510(k) clearance K022387 · decided 2002-09-19
Clearance details
- K-number
- K022387
- Device name
- CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
- Applicant
- Craftmatic Organization, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-23
- Decision date
- 2002-09-19
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LLI
- Device class
- 2
- Regulation number
- 880.5100
- 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 |
|---|---|---|
| CRAFTMATIC ELECTRIC ADJUSTABLE BED (K840787) | Contour, Inc. | 1984-06-13 |
Recalls involving this device
No recalls on record reference this clearance.