BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
FDA 510(k) clearance K023245 · decided 2002-10-21
Clearance details
- K-number
- K023245
- Device name
- BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
- Applicant
- Paradigm Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-30
- Decision date
- 2002-10-21
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- NJJ
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.