FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K Number: K991211
·
Decision Jul 8, 1999
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
12
Review Days
90
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Basic Information
- Device Name
- EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
- K Number
- K991211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reynolds Medical , Ltd.
- Date Received
- April 9, 1999
- Decision Date
- July 8, 1999
- 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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| 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 |