ABN ANEROID SPHYGMOMANOMETER
FDA 510(k) clearance K012444 · decided 2001-08-16
Clearance details
- K-number
- K012444
- Device name
- ABN ANEROID SPHYGMOMANOMETER
- Applicant
- Pt. Sugih Instrumendo Abadi
- Decision
- Substantially Equivalent
- Date received
- 2001-08-01
- Decision date
- 2001-08-16
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hauppauge, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.