FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
K Number: K991293
·
Decision May 5, 2000
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
17
Applicant Total
1
Review Days
386
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Basic Information
- Device Name
- EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
- K Number
- K991293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1750
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Medical Technologies, Inc.
- Date Received
- April 15, 1999
- Decision Date
- May 5, 2000
- 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 |
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