KEYMED OFFICE COUCH
FDA 510(k) clearance K854304 · decided 1985-11-12
Clearance details
- K-number
- K854304
- Device name
- KEYMED OFFICE COUCH
- Applicant
- Keymed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-25
- Decision date
- 1985-11-12
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FPO
- Device class
- 2
- Regulation number
- 880.6910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Essex Ss2 5qh England, GB
- 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 |
|---|---|---|
| POWER-LOAD COT FASTENER SYSTEM (K113598) | Stryker Medical | 2011-12-20 |
| IRSG I-MOVER FOR BEDS (K072598) | International Retail Services Group, LLC | 2008-04-14 |
| DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (K972528) | Dyna Corp. | 1997-07-28 |
| ADULT-PEDIATRIC TRANSPORT SYSTEM (K955766) | International Biomedical, Inc. | 1996-08-07 |
| HARE MODEL 2000 EZ LOADER MODEL 95555 (K962181) | Dyna Corp. | 1996-08-01 |
| WHEELED STRETCHER (K961437) | Hill-Rom, Inc. | 1996-06-03 |
| HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (K952447) | Hill-Rom, Inc. | 1995-11-22 |
| EMERGENCY/ACCIDENT TROLLEY 550 (K946101) | Hogan & Hartson | 1995-02-07 |
| MODEL 792 CONVERGE, MODEL 793 VISION 2000 (K945431) | Hausted, Inc. | 1995-01-25 |
| MODEL 578 MOBILE SURGICAL STRETCHER (K943969) | Hausted, Inc. | 1995-01-25 |
| STRYKER POWERED STRETCHER (K942948) | Stryker Corp. | 1995-01-24 |
| PATIENT TROLLEY 545 (K943528) | Merivaara Instrumentarium Corp. | 1994-10-04 |
Recalls involving this device
No recalls on record reference this clearance.