Atlas FDA

GONIOMETER, INTER. STAND. LARGE, BK7514

FDA 510(k) clearance K760302 · decided 1976-09-08

Clearance details

K-number
K760302
Device name
GONIOMETER, INTER. STAND. LARGE, BK7514
Applicant
Fred Sammons, Inc.
Decision
Substantially Equivalent
Date received
1976-07-23
Decision date
1976-09-08
Days to decision
47 days
Clearance type
Traditional
Product code
KQW
Device class
1
Regulation number
888.1520
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, 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.

RecordFirmDate
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
HAND HELD GONIOMETER (K850082)Chattanooga Group, Inc.1985-04-04
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

Recalls involving this device

No recalls on record reference this clearance.