BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
FDA 510(k) clearance K983717 · decided 1999-09-16
Clearance details
- K-number
- K983717
- Device name
- BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
- Applicant
- Aerotel Medical Systems (1998) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-21
- Decision date
- 1999-09-16
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Holon, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.