FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PECGASYS REMOTE TRANSMISSION UNIT
K Number: K831092
·
Decision Jul 19, 1983
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
2
Review Days
106
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Basic Information
- Device Name
- PECGASYS REMOTE TRANSMISSION UNIT
- K Number
- K831092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Datamedix
- Date Received
- April 4, 1983
- Decision Date
- July 19, 1983
- 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 Datamedix
| K Number | Device Name | ||
|---|---|---|---|
| K810027 | DATAMEDIX PECGASYS SYSTEM | Mar 26, 1981 | Substantially Equivalent |