FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PUPIL PATHWAY ANALYZER (PPA)
K Number: K895609
·
Decision Nov 2, 1989
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
2
Applicant Total
1
Review Days
45
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Basic Information
- Device Name
- PUPIL PATHWAY ANALYZER (PPA)
- K Number
- K895609
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Pulse Medical Instruments
- Date Received
- September 18, 1989
- Decision Date
- November 2, 1989
- Product Code
- HLG
- 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 |
|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | FDA class 1 | Ophthalmic |
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