FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE SOFT-TEMP
K Number: K962983
·
Decision Jan 10, 1997
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
6
Review Days
162
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Basic Information
- Device Name
- STERILE SOFT-TEMP
- K Number
- K962983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adroit Medical Systems, Inc.
- Date Received
- August 1, 1996
- Decision Date
- January 10, 1997
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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Other Clearances by Adroit Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 | Jun 6, 2008 | Substantially Equivalent |
| K973981 | SAFEPASS STERILIZATION POUCH | Jan 29, 1998 | Substantially Equivalent |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | Sep 10, 1997 | Substantially Equivalent |
| K921920 | SOFT-TEMP | Dec 11, 1992 | Substantially Equivalent |
| K921928 | SOFT-COVER | Nov 6, 1992 | Substantially Equivalent |