FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NONINVASIVE TEMPORARY PACEMAKER
K Number: K822246
·
Decision Aug 6, 1982
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
83
Applicant Total
2
Review Days
8
Basic Information
- Device Name
- NONINVASIVE TEMPORARY PACEMAKER
- K Number
- K822246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- ROSS RESEARCH, INC.
- Date Received
- July 29, 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 ROSS RESEARCH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K840353 | PACEMAKER PULSE GENERATOR W/ELECTRODE | Apr 23, 1984 | Substantially Equivalent |