FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRA-WIDE SAFETY SPECTACLE FRAME
K Number: K813156
·
Decision Dec 14, 1981
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
8
Review Days
38
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Basic Information
- Device Name
- ULTRA-WIDE SAFETY SPECTACLE FRAME
- K Number
- K813156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Zee Medical Products Co., Inc.
- Date Received
- November 6, 1981
- Decision Date
- December 14, 1981
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQZ), ordered by most recent decision date.
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
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SPECTACLE FRAME
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OPTICAL FRAMES
FDA 510(k)
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FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Zee Medical Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823501 | ZEE SPHYGMOMANOMETER | Jan 21, 1983 | Substantially Equivalent |
| K813016 | ZEE TRACTION SPLINT | Nov 24, 1981 | Substantially Equivalent |
| K812814 | ZEE SURGICAL INSTRUMENTS | Nov 6, 1981 | Substantially Equivalent |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | Oct 23, 1981 | Substantially Equivalent |
| K812342 | ZEE EXTRICATION DEVICE | Sep 21, 1981 | Substantially Equivalent |
| K812284 | ZEE ELECTRODE-GEL | Sep 8, 1981 | Substantially Equivalent |
| K812022 | ZEE MANUAL RESUSCITATOR | Jul 31, 1981 | Substantially Equivalent |