FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITERION II PACING SYSTEM MONITORS
K Number: K802325
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- CRITERION II PACING SYSTEM MONITORS
- K Number
- K802325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dart Medical Equipment
- Date Received
- September 23, 1980
- Decision Date
- October 23, 1980
- 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 Dart Medical Equipment
| K Number | Device Name | ||
|---|---|---|---|
| K820986 | EKG MONITORS, VARIOUS MODELS | Apr 29, 1982 | Substantially Equivalent |
| K820904 | EKG TELEPHONE CONVERTER | Apr 21, 1982 | Substantially Equivalent |
| K820828 | SAMM | Apr 14, 1982 | Substantially Equivalent |
| K803315 | CRITERION II RHYTHM PROFILE MONITOR | Jan 22, 1981 | Substantially Equivalent |
| K802782 | THE CRITERION II PACING SYS. MONITOR | Nov 19, 1980 | Substantially Equivalent |
| K800286 | CRITERION II PACING SYSTEM MONITORS | Mar 12, 1980 | Substantially Equivalent |