FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD FLOW ANALYZER
K Number: K970887
·
Decision Jun 17, 1997
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
10
Review Days
98
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Basic Information
- Device Name
- BLOOD FLOW ANALYZER
- K Number
- K970887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paradigm Medical Industries, Inc.
- Date Received
- March 11, 1997
- Decision Date
- June 17, 1997
- Product Code
- HKY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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Other Clearances by Paradigm Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | May 26, 2005 | Substantially Equivalent |
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Oct 21, 2002 | Substantially Equivalent |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | May 22, 2001 | Substantially Equivalent |
| K003141 | UBM PLUS, MODEL P45 | Dec 5, 2000 | Substantially Equivalent |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | Oct 6, 2000 | Substantially Equivalent |
| K981109 | QUITETIP | Jun 9, 1998 | Substantially Equivalent |
| K974719 | PHACOPAK | Jan 20, 1998 | Substantially Equivalent |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Jul 14, 1997 | Substantially Equivalent |
| K953447 | PRECISIONIST THIRTY THOUSAND | Oct 13, 1995 | Substantially Equivalent |