ABP FOR WINDOWS
FDA 510(k) clearance K021517 · decided 2002-07-24
Clearance details
- K-number
- K021517
- Device name
- ABP FOR WINDOWS
- Applicant
- Rozinn Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-10
- Decision date
- 2002-07-24
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DSK
- Device class
- 2
- Regulation number
- 870.1110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Glendale, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.