FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTROMOT K2 CPM
K Number: K931555
·
Decision Jan 31, 1994
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
23
Review Days
307
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Basic Information
- Device Name
- ARTROMOT K2 CPM
- K Number
- K931555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormed Mfg., Inc.
- Date Received
- March 30, 1993
- Decision Date
- January 31, 1994
- 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 Ormed Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882528 | CYLINDRICAL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882530 | TAPE STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882527 | GAUZE SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K880853 | CHERRY SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880907 | TRIANGLE SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880910 | ROUND STICK SPONGES | Mar 17, 1988 | Substantially Equivalent |
| K880911 | BLUNT SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880851 | FLAT STICK SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880852 | ROSEBUD DISSECTORS | Mar 17, 1988 | Substantially Equivalent |