MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
FDA 510(k) clearance K920429 · decided 1993-07-20
Clearance details
- K-number
- K920429
- Device name
- MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-03
- Decision date
- 1993-07-20
- Days to decision
- 533 days
- Clearance type
- Traditional
- Product code
- MLD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.