FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACER MONITOR, PULSE WIDTH
K Number: K772178
·
Decision Dec 8, 1977
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
10
Review Days
16
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Basic Information
- Device Name
- PACER MONITOR, PULSE WIDTH
- K Number
- K772178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Survival Technology, Inc.
- Date Received
- November 22, 1977
- Decision Date
- December 8, 1977
- 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 Survival Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925535 | CARDIOBEEPER(R) CB-IIA | Jan 28, 1993 | Substantially Equivalent |
| K894799 | CARDIOBEEPER MEMORY MONITOR CB 600 SERIES | Oct 3, 1989 | Substantially Equivalent |
| K890461 | CARDIOBEEPER IV | Feb 23, 1989 | Substantially Equivalent |
| K883843 | CARDIOBEEPER II | Nov 9, 1988 | Substantially Equivalent |
| K883614 | CYTOGUARD(R) | Sep 15, 1988 | Substantially Equivalent |
| K880300 | CARDIOBEEPER(R) III | May 12, 1988 | Substantially Equivalent |
| K844966 | CARDIOBEEPER PROFILE MONITOR | Feb 8, 1985 | Substantially Equivalent |
| K822093 | STAT-SCAN | Sep 21, 1982 | Substantially Equivalent |
| K813101 | CARDIOBEEPER MEMORY MONITOR | Nov 27, 1981 | Substantially Equivalent |