FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
K Number: K935590
·
Decision May 5, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
17
Applicant Total
3
Review Days
168
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
- K Number
- K935590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1750
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ep Medical, Inc.
- Date Received
- November 18, 1993
- Decision Date
- May 5, 1994
- Product Code
- JOQ
- 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 |
|---|---|---|---|
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOQ), ordered by most recent decision date.
Bloom2 Programmable Electrophysiology Stimulator
FDA 510(k)
FDA Class 2
·Cardiovascular
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
FDA 510(k)
FDA Class 2
·Cardiovascular
STIMLAB
FDA 510(k)
FDA Class 2
·Cardiovascular
Z6 STIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EP-4 CLINICAL STIMUTATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EP-4 CLINICAL STIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular