ERG-JET ELECTRODE
FDA 510(k) clearance K823767 · decided 1983-01-08
Clearance details
- K-number
- K823767
- Device name
- ERG-JET ELECTRODE
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-14
- Decision date
- 1983-01-08
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HLF
- Device class
- 1
- Regulation number
- 886.1430
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MARCO STANDARD RADIUSGAUGES (K930437) | Marco Ophthalmic, Inc. | 1993-08-09 |
| BAUSCH & LOMB CONTACT LENS VIEWER (K862517) | Bausch & Lomb, Inc. | 1986-08-11 |
Recalls involving this device
No recalls on record reference this clearance.