BTX — Board, Arm (With Cover), Sterile Class I
FDA product code BTX covers "Board, Arm (With Cover), Sterile", a Class I medical device regulated under 21 CFR 878.3910. Submissions are reviewed by the General, Plastic Surgery panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTX
- Device Class
- Class I
- Regulation Number
- 878.3910
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K935098 | sentry medical products | BABY BOARD | February 15, 1994 |
| K900175 | infection control products | 4/1 ARMBOARD | January 24, 1990 |
| K884838 | edgewater medical systems | ALLEN PRONE ARMBOARD | December 15, 1988 |
| K882524 | karlin technology | UNIVERSALLY ADJUSTABLE ARMBOARD | July 8, 1988 |
| K881292 | edgewater medical systems | ALLEN LATERAL ARMBOARD | April 7, 1988 |
| K864670 | anago | BOARD, ARM (WITH COVER) | January 12, 1987 |
| K833664 | rick robbin and frederick auerbach | ARMBOARD AND THE BOARD | December 27, 1983 |
| K830018 | harvey a. turner, m.d | SAFE-T ARM BOARD | January 26, 1983 |
| K823412 | sage products | ARM BOARD W/I.V COVERING | December 15, 1982 |
| K811419 | datamed | SPRIO-LOOP | June 12, 1981 |
| K792147 | medical innovations | ARM SHIELD FOR ANESTHESIA | December 6, 1979 |
| K781233 | fibre formations | IV ARMBOARDS | August 14, 1978 |
| K770391 | precept | COVER, ARMBOARD, DISPOSABLE | March 7, 1977 |