JUMP START, MODEL 970300
FDA 510(k) clearance K021168 · decided 2002-06-26
Clearance details
- K-number
- K021168
- Device name
- JUMP START, MODEL 970300
- Applicant
- Medical Research Laboratories, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 2002-04-11
- Decision date
- 2002-06-26
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Buffalo Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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