FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHFINDER 700 HOLTER ANALYZER
K Number: K951902
·
Decision Jul 15, 1996
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
12
Review Days
448
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Basic Information
- Device Name
- PATHFINDER 700 HOLTER ANALYZER
- K Number
- K951902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reynolds Medical , Ltd.
- Date Received
- April 24, 1995
- Decision Date
- July 15, 1996
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Reynolds Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K024283 | CARDIODIRECT, MODELS 12M, 12I, 12S | Aug 1, 2003 | Substantially Equivalent |
| K013367 | CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH | Dec 13, 2001 | Substantially Equivalent |
| K011345 | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM | Jul 20, 2001 | Substantially Equivalent |
| K011837 | LIFECARD CF 7 DAY | Jul 13, 2001 | Substantially Equivalent |
| K001025 | LIFECARD CF COMPACT RECORDER | Apr 19, 2000 | Substantially Equivalent |
| K991211 | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM | Jul 8, 1999 | Substantially Equivalent |
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER | Dec 4, 1997 | Substantially Equivalent |
| K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER | Oct 20, 1994 | Substantially Equivalent |
| K884126 | E-RAM | Oct 30, 1989 | Substantially Equivalent |
| K871344 | PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR | Oct 20, 1987 | Substantially Equivalent |