FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ERG-JET ELECTRODE
K Number: K823767
·
Decision Jan 8, 1983
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
2
Applicant Total
68
Review Days
25
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Basic Information
- Device Name
- ERG-JET ELECTRODE
- K Number
- K823767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1430
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- December 14, 1982
- Decision Date
- January 8, 1983
- Product Code
- HLF
- 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 |
|---|---|---|---|
| HLF | Device, Measuring, Lens Radius, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HLF), ordered by most recent decision date.
MARCO STANDARD RADIUSGAUGES
FDA 510(k)
FDA Class 1
·Ophthalmic
BAUSCH & LOMB CONTACT LENS VIEWER
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Life-Tech Intl., Inc.
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|---|---|---|---|
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| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |