FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACE* AID MODEL 50
K Number: K820507
·
Decision Aug 6, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
17
Review Days
162
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Basic Information
- Device Name
- PACE* AID MODEL 50
- K Number
- K820507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Resucitator Corp.
- Date Received
- February 25, 1982
- Decision Date
- August 6, 1982
- Product Code
- DRO
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiac Resucitator Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K882513 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Jul 12, 1988 | Substantially Equivalent |
| K871971 | MODIFIED PACE*AID MODEL 53 | Jun 24, 1987 | Substantially Equivalent |
| K871538 | STAT-PAD (TM) | Jun 24, 1987 | Substantially Equivalent |
| K871569 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR | Jun 8, 1987 | Substantially Equivalent |
| K870622 | HEART*AID 1000 | Apr 10, 1987 | Substantially Equivalent |
| K850596 | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & | Mar 6, 1985 | Substantially Equivalent |
| K850170 | HEART AID MODEL 97 | Feb 14, 1985 | Substantially Equivalent |
| K844811 | PACE AID MODEL 53 | Jan 24, 1985 | Substantially Equivalent |
| K843547 | PACE *AID MODEL 52 | Dec 17, 1984 | Substantially Equivalent |
| K843358 | HEART-AID MODEL 80 | Nov 19, 1984 | Substantially Equivalent |