510(k) K881292
- Device
- ALLEN LATERAL ARMBOARD
- Applicant
- EDGEWATER MEDICAL SYSTEMS, INC.
- 510(k) number
- K881292
- Product code
- BTX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-07
- Date received
- 1988-03-28
- Regulation
- 878.3910
- Classification name
- Board, Arm (with Cover), Sterile
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL ALLEN
- Address
- 6263 Mayfield Rd. #206 Mayfield Hts. OH US 44124 44124
FDA Registration Numbers#
- 3001650535
- 2027062
- 1643116
- 3018269545
- 1417592
- 1424263
- 9681860
- 3015173212
- 3014579161
- 3009655869
- 1423537
- 3017264244
- 1450662
- 2032098
- 3004122598
- 1921846
- 2029275
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BTX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935098 | BABY BOARD | Sentry Medical Products, Inc. | 1994-02-15 |
| K900175 | 4/1 ARMBOARD | Infection Control Products, Inc. | 1990-01-24 |
| K884838 | ALLEN PRONE ARMBOARD | Edgewater Medical Systems, Inc. | 1988-12-15 |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Karlin Technology, Inc. | 1988-07-08 |
| K864670 | BOARD, ARM (WITH COVER) | Anago, Inc. | 1987-01-12 |
| K833664 | ARMBOARD AND THE BOARD | Rick Robbin & Frederick Auerbach | 1983-12-27 |
| K830018 | SAFE-T ARM BOARD | Harvey A. Turner, M.D. | 1983-01-26 |
| K823412 | ARM BOARD W/I.V COVERING | Sage Products, Inc. | 1982-12-15 |
| K811419 | SPRIO-LOOP | Datamed, Inc. | 1981-06-12 |
| K792147 | ARM SHIELD FOR ANESTHESIA | Medical Innovations Corp. | 1979-12-06 |
| K781233 | IV ARMBOARDS | Fibre Formations, Inc. | 1978-08-14 |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Precept, Inc. | 1977-03-07 |
Legacy Summary#
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FDA Review#
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