FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOX EYE SHIELDS
K Number: K810098
·
Decision Feb 27, 1981
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
56
Review Days
39
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FOX EYE SHIELDS
- K Number
- K810098
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Hospital Supply Corp.
- Date Received
- January 19, 1981
- Decision Date
- February 27, 1981
- Product Code
- HOY
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOY), ordered by most recent decision date.
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
FDA 510(k)
FDA Class 1
·Ophthalmic
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
FDA 510(k)
FDA Class 1
·Ophthalmic
ARCTIC PREMIER SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
GOGGLE SAFEGUARD
FDA 510(k)
FDA Class 1
·Ophthalmic
SHIELD, EYE, OPHTHALMIC
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by American Hospital Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854739 | AMERICAN STERILE SURGICAL ABSORBENT TOWEL | Dec 27, 1985 | Substantially Equivalent |
| K854759 | AMERICAN STERILE MAYO STAND TRAY | Dec 17, 1985 | Substantially Equivalent |
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent |
| K830343 | CONTAINER W/PRIMING SOLUTION | Mar 17, 1983 | Substantially Equivalent |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | Feb 25, 1983 | Substantially Equivalent |
| K822755 | LATEX PENROSE TUBING | Jan 21, 1983 | Substantially Equivalent |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | Dec 3, 1982 | Substantially Equivalent |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |