FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K Number: K961582
·
Decision Nov 8, 1996
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
29
Applicant Total
9
Review Days
198
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Basic Information
- Device Name
- EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
- K Number
- K961582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3630
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Technical Services Corp.
- Date Received
- April 24, 1996
- Decision Date
- November 8, 1996
- Product Code
- DTC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTC | Analyzer, Pacemaker Generator Function | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K932204 | E-Z THERM 3 SECOND THERMOMETER | Oct 3, 1994 | Substantially Equivalent |
| K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. | Sep 10, 1992 | Substantially Equivalent |