510(k) K023245
- Device
- BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
- Applicant
- PARADIGM MEDICAL INDUSTRIES, INC.
- 510(k) number
- K023245
- Product code
- NJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-21
- Date received
- 2002-09-30
- Regulation
- 886.1930
- Classification name
- Tonometer, Analyzer, Ocular Blood Flow
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M SILVER
- Address
- 2355 S. 1070 W. Salt Lake City UT US 84119 84119
FDA Registration Numbers#
- 1721676
- 1226586
Source Documents#
Legacy Summary#
summary
FDA Review#
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