BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
FDA 510(k) clearance K971616 · decided 1998-11-04
Clearance details
- K-number
- K971616
- Device name
- BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
- Applicant
- Data Sciences Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-02
- Decision date
- 1998-11-04
- Days to decision
- 551 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.