HAND HELD GONIOMETER
FDA 510(k) clearance K850082 · decided 1985-04-04
Clearance details
- K-number
- K850082
- Device name
- HAND HELD GONIOMETER
- Applicant
- Chattanooga Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-10
- Decision date
- 1985-04-04
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- KQW
- Device class
- 1
- Regulation number
- 888.1520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Red Bank, TN, 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 |
|---|---|---|
| O'BRIEN GONIOMETER (K926237) | Sgarlato Laboratories, Inc. | 1993-08-02 |
| DOBBHOFF(R) RETRIEVAL FORCEPS (K901744) | Biosearch Medical Products, Inc. | 1990-07-03 |
| THE (CROM) TESTER (K870767) | Twin City Surgical, Inc. | 1987-03-17 |
| FINGER BONIOMETER BK7506 (K831550) | Fred Sammons, Inc. | 1983-06-24 |
| THE TELOS EQUIPMENT (K812778) | The Telos Co. | 1981-12-08 |
| UNIVERSAL GONIMETER (K810441) | Fred Sammons, Inc. | 1981-02-27 |
| BK-7497 BULB DYNAMOMETER (K801715) | Fred Sammons, Inc. | 1980-08-04 |
| BK-7505 RADIOPAQUE GONIOMETER, 8 (K801716) | Fred Sammons, Inc. | 1980-08-04 |
| BK-7511 BRASS GONIOMETER (K801717) | Fred Sammons, Inc. | 1980-08-04 |
| BK-7513 STAINLESS STEEL GONIOMETER (K801718) | Fred Sammons, Inc. | 1980-08-04 |
| GONIOMETER, MED. INTER. STAND. BK-7512 (K760301) | Fred Sammons, Inc. | 1976-09-08 |
| GONIOMETER, INTER. STAND. LARGE, BK7514 (K760302) | Fred Sammons, Inc. | 1976-09-08 |
Recalls involving this device
No recalls on record reference this clearance.