LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
FDA 510(k) clearance K872928 · decided 1988-01-06
Clearance details
- K-number
- K872928
- Device name
- LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
- Applicant
- Fidelity Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-27
- Decision date
- 1988-01-06
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Millburn, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.