FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-Z THERM 3 SECOND THERMOMETER
K Number: K932204
·
Decision Oct 3, 1994
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
9
Review Days
515
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Basic Information
- Device Name
- E-Z THERM 3 SECOND THERMOMETER
- K Number
- K932204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Technical Services Corp.
- Date Received
- May 6, 1993
- Decision Date
- October 3, 1994
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by North American Technical Services Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K974321 | HYDROTONE | Jun 22, 1998 | Substantially Equivalent |
| K970592 | N/A | Jun 13, 1997 | Substantially Equivalent |
| K970590 | N/A | Jun 13, 1997 | Substantially Equivalent |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | Nov 8, 1996 | Substantially Equivalent |
| K953440 | ELLMAN LAPTRODE | Aug 29, 1995 | Substantially Equivalent |
| K944558 | ELLMAN VAPOR-VAC II | Apr 28, 1995 | Substantially Equivalent |
| K944730 | MASSAGER | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. | Sep 10, 1992 | Substantially Equivalent |