FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GONIOMETER, MED. INTER. STAND. BK-7512
K Number: K760301
·
Decision Sep 8, 1976
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
12
Applicant Total
278
Review Days
47
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Basic Information
- Device Name
- GONIOMETER, MED. INTER. STAND. BK-7512
- K Number
- K760301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- July 23, 1976
- Decision Date
- September 8, 1976
- Product Code
- KQW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KQW | Goniometer, Nonpowered | FDA class 1 | Orthopedic |
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Other Clearances by Fred Sammons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | May 6, 1988 | Substantially Equivalent |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Apr 1, 1988 | Substantially Equivalent |
| K831549 | ARM SLINGS | Jun 30, 1983 | Substantially Equivalent |
| K831548 | SPLINTS | Jun 27, 1983 | Substantially Equivalent |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 | Substantially Equivalent |
| K831550 | FINGER BONIOMETER BK7506 | Jun 24, 1983 | Substantially Equivalent |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Jun 24, 1983 | Substantially Equivalent |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Jun 16, 1983 | Substantially Equivalent |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Jun 8, 1983 | Substantially Equivalent |