FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISITEC MAGNIFYING SPECTACLES
K Number: K844038
·
Decision Nov 29, 1984
Classifications
1
FEI Numbers
664
Registration Numbers
664
Same Product Code
10
Applicant Total
49
Review Days
44
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Basic Information
- Device Name
- VISITEC MAGNIFYING SPECTACLES
- K Number
- K844038
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5840
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Visitec Co.
- Date Received
- October 16, 1984
- Decision Date
- November 29, 1984
- Product Code
- HOI
- 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 |
|---|---|---|---|
| HOI | Spectacle, Magnifying | FDA class 1 | Ophthalmic |
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Other Clearances by Visitec Co.
| K Number | Device Name | ||
|---|---|---|---|
| K953394 | VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} | Oct 12, 1995 | Substantially Equivalent |
| K945114 | VISITEC SCLERAL PLUG | Feb 23, 1995 | Substantially Equivalent |
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Feb 14, 1995 | Substantially Equivalent |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Jan 17, 1995 | Substantially Equivalent |
| K942234 | VISITEC PRECISE-POINT | Jul 12, 1994 | Substantially Equivalent |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 | Substantially Equivalent |
| K940210 | VISITEC EYE PAD | Mar 7, 1994 | Substantially Equivalent |
| K933872 | VISI-SPEAR EYE SPONGE | Dec 27, 1993 | Substantially Equivalent |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Nov 4, 1992 | Substantially Equivalent |
| K922530 | VISITEC MICROSURGICAL SUTURE | Oct 20, 1992 | Substantially Equivalent |