FDA 510(k)
Substantially Equivalent
🇺🇸 United States
THERMA-SCAN
K Number: K820941
·
Decision Jun 16, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
71
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Basic Information
- Device Name
- THERMA-SCAN
- K Number
- K820941
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- T. G. & E. Medical
- Date Received
- April 6, 1982
- Decision Date
- June 16, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
Other Clearances by T. G. & E. Medical
| K Number | Device Name | ||
|---|---|---|---|
| K860706 | IV BAND (INTRAVENOUS CATHETER ASSESORY) | Mar 21, 1986 | Substantially Equivalent |
| K860261 | CANNULA BAND | Feb 18, 1986 | Substantially Equivalent |
| K823221 | ACCA-TEMP SKIN TEMP. VINYL DISC | Jan 12, 1983 | Substantially Equivalent |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | Mar 5, 1982 | Substantially Equivalent |