FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNATEK 40
K Number: K982907
·
Decision Oct 2, 1998
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
7
Review Days
45
Basic Information
- Device Name
- MAGNATEK 40
- K Number
- K982907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MAGNA ADVANCED TECHNOLOGIES, INC.
- Date Received
- August 18, 1998
- Decision Date
- October 2, 1998
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by MAGNA ADVANCED TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K991819 | MAGNATEK 30 | Aug 19, 1999 | Substantially Equivalent |
| K983114 | MAGNATEK80 | Sep 22, 1998 | Substantially Equivalent |
| K982846 | MTEK-1400 | Sep 18, 1998 | Substantially Equivalent |
| K982405 | MTEK-1000 | Sep 17, 1998 | Substantially Equivalent |
| K981310 | MAGNATEK C-300 | Jul 9, 1998 | Substantially Equivalent |
| K981416 | MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 | Jun 24, 1998 | Substantially Equivalent |