FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K Number: K884897
·
Decision Mar 9, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
34
Review Days
106
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Basic Information
- Device Name
- FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
- K Number
- K884897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mennen Medical, Inc.
- Date Received
- November 23, 1988
- Decision Date
- March 9, 1989
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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