FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOG-A-RYTHM MODEL 100 AND MODEL 1001
K Number: K952790
·
Decision Oct 17, 1996
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
1
Review Days
486
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Basic Information
- Device Name
- LOG-A-RYTHM MODEL 100 AND MODEL 1001
- K Number
- K952790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nian-Crae, Inc.
- Date Received
- June 19, 1995
- Decision Date
- October 17, 1996
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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