BOARD, ARM (WITH COVER)
FDA 510(k) clearance K864670 · decided 1987-01-12
Clearance details
- K-number
- K864670
- Device name
- BOARD, ARM (WITH COVER)
- Applicant
- Anago, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-02
- Decision date
- 1987-01-12
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- BTX
- Device class
- 1
- Regulation number
- 878.3910
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Worth, TX, 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 |
|---|---|---|
| BABY BOARD (K935098) | Sentry Medical Products, Inc. | 1994-02-15 |
| 4/1 ARMBOARD (K900175) | Infection Control Products, Inc. | 1990-01-24 |
| ALLEN PRONE ARMBOARD (K884838) | Edgewater Medical Systems, Inc. | 1988-12-15 |
| UNIVERSALLY ADJUSTABLE ARMBOARD (K882524) | Karlin Technology, Inc. | 1988-07-08 |
| ALLEN LATERAL ARMBOARD (K881292) | Edgewater Medical Systems, Inc. | 1988-04-07 |
| ARMBOARD AND THE BOARD (K833664) | Rick Robbin & Frederick Auerbach | 1983-12-27 |
| SAFE-T ARM BOARD (K830018) | Harvey A. Turner, M.D. | 1983-01-26 |
| ARM BOARD W/I.V COVERING (K823412) | Sage Products, Inc. | 1982-12-15 |
| SPRIO-LOOP (K811419) | Datamed, Inc. | 1981-06-12 |
| ARM SHIELD FOR ANESTHESIA (K792147) | Medical Innovations Corp. | 1979-12-06 |
| IV ARMBOARDS (K781233) | Fibre Formations, Inc. | 1978-08-14 |
| COVER, ARMBOARD, DISPOSABLE (K770391) | Precept, Inc. | 1977-03-07 |
Recalls involving this device
No recalls on record reference this clearance.