FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOMETER
K Number: K780117
·
Decision Feb 3, 1978
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
12
Review Days
11
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Basic Information
- Device Name
- CARDIOMETER
- K Number
- K780117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Med General
- Date Received
- January 23, 1978
- Decision Date
- February 3, 1978
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Med General
| K Number | Device Name | ||
|---|---|---|---|
| K791097 | CEPTORTRODE WITH CEPTOR HESIVE | Aug 3, 1979 | Substantially Equivalent |
| K791098 | SINGLE-USE MINI-BULLDOG | Jun 22, 1979 | Substantially Equivalent |
| K790763 | MAXI-VAC TM | Apr 23, 1979 | Substantially Equivalent |
| K790269 | CEPTOR HESIVE | Feb 26, 1979 | Substantially Equivalent |
| K782006 | MEDGENERAL SINGLE-USE BULLDOG | Dec 15, 1978 | Substantially Equivalent |
| K781239 | MYO-STIM | Nov 3, 1978 | Substantially Equivalent |
| K780632 | MAXICEPTOR | Aug 14, 1978 | Substantially Equivalent |
| K780698 | STIMULATORS, NERVE, ELECTRICAL | May 12, 1978 | Substantially Equivalent |
| K771701 | VESSEL-CLUDE | Dec 13, 1977 | Substantially Equivalent |
| K771702 | VESSEL-STABILIZER | Dec 13, 1977 | Substantially Equivalent |