FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL MAGNETIC TAPE RECORDER
K Number: K802564
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- MEDICAL MAGNETIC TAPE RECORDER
- K Number
- K802564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Concepts, Inc.
- Date Received
- October 17, 1980
- Decision Date
- November 12, 1980
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Medical Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | Sep 13, 2011 | Substantially Equivalent |
| K940283 | KARL STORZ ENDOVISION UROCAM/HYSTEROCAM | Sep 28, 1994 | Substantially Equivalent |
| K883943 | CCM-1 VIDEO CAMERA SYSTEM | Sep 28, 1988 | Substantially Equivalent |
| K883944 | MEC-1 VIDEO COMBO SYSTEM | Sep 28, 1988 | Substantially Equivalent |