FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N/A
K Number: K970590
·
Decision Jun 13, 1997
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
9
Review Days
115
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Basic Information
- Device Name
- N/A
- K Number
- K970590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North American Technical Services Corp.
- Date Received
- February 18, 1997
- Decision Date
- June 13, 1997
- Product Code
- ILY
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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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 |
| 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 |
| 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 |