FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIODIRECT, MODELS 12M, 12I, 12S
K Number: K024283
·
Decision Aug 1, 2003
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
12
Review Days
221
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Basic Information
- Device Name
- CARDIODIRECT, MODELS 12M, 12I, 12S
- K Number
- K024283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reynolds Medical , Ltd.
- Date Received
- December 23, 2002
- Decision Date
- August 1, 2003
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| K951902 | PATHFINDER 700 HOLTER ANALYZER | Jul 15, 1996 | 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 |