FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
K Number: K942586
·
Decision May 10, 1995
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
5
Review Days
363
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Basic Information
- Device Name
- CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
- K Number
- K942586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Telescan Medical Systems
- Date Received
- May 12, 1994
- Decision Date
- May 10, 1995
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Telescan Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K924187 | INSTANT MEMORY 2000 | Jun 16, 1993 | Substantially Equivalent |
| K883358 | TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM | Oct 13, 1988 | Substantially Equivalent |
| K871587 | THE TELESCAN C.A.R.E. SYSTEM | Aug 12, 1987 | Substantially Equivalent |
| K820276 | TELESCAN T-30 | Feb 12, 1982 | Substantially Equivalent |