FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACESTART
K Number: K872778
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
1
Review Days
113
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Basic Information
- Device Name
- PACESTART
- K Number
- K872778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pacific Rim Engineering & Mfg.
- Date Received
- July 14, 1987
- Decision Date
- November 4, 1987
- 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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