510(k) K910601
- Device
- PATHFINDER
- Applicant
- NURION INDUSTRIES
- 510(k) number
- K910601
- Product code
- HPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-14
- Date received
- 1991-02-13
- Regulation
- 886.5900
- Classification name
- Aid, Vision, Electronic, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM P ROSEN
- Address
- Station Sq. Three Paoli PA US 19301 19301
FDA Registration Numbers#
- 3010577752
- 3009840810
- 3014656175
- 3034880867
- 3003951061
- 3002968900
- 9612197
- 8022025
- 3042371163
- 3014656174
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910124 | LOW VISION ENHANCEMENT SYSTEM (LVES) | Triangle Investments | 1991-04-10 |
| K903558 | LASER CANE | Nurion Industries | 1990-09-27 |
| K902187 | POLARON | Nurion Industries | 1990-08-08 |
| K862338 | SENSORY 6 | Brytech, Inc. | 1986-09-03 |
| K823385 | ALES | Oms | 1983-03-09 |
| K761215 | F4912 NIGHT VISION AID | Itt Corp. | 1976-12-16 |
Legacy Summary#
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FDA Review#
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