FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTTER CPM
K Number: K823539
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
11
Review Days
45
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Basic Information
- Device Name
- SUTTER CPM
- K Number
- K823539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Sutter Biomedical, Inc.
- Date Received
- November 30, 1982
- Decision Date
- January 14, 1983
- Product Code
- BXB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Sutter Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875249 | SUTTER PHALANGEAL CAP | Feb 3, 1988 | Substantially Equivalent |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Oct 9, 1987 | Substantially Equivalent |
| K861983 | SUTTER LESSER METATARSAL CAP | Sep 8, 1986 | Substantially Equivalent |
| K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT | Apr 25, 1985 | Substantially Equivalent |
| K830974 | SUTTER CPM 5000 | Apr 12, 1983 | Substantially Equivalent |
| K830649 | SUTTER CPM 2000 | Mar 17, 1983 | Substantially Equivalent |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | May 21, 1982 | Substantially Equivalent |
| K820083 | SUTTER CPM | Jan 28, 1982 | Substantially Equivalent |
| K812691 | SILICONE IMPLANTS | Nov 16, 1981 | Substantially Equivalent |
| K802342 | PROXIMAL INTERPHALANGEAL JOINT IMPLANT | Oct 14, 1981 | Substantially Equivalent |