FDA Product Code
FDA Product Code HLT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1640
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | Chalgren Enterprises, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K921815 | TOMEY PE-300 PORTABLE ERG | Tomey Corporation USA | 1992-07-15 | Traditional | PDF ↗ |
| K841293 | PANORAMIC LOUPES - VARIOUS | Keller Instruments, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K781543 | ORBIOGRAPH | Sonometrics Systems, Inc. | 1978-10-24 | Traditional | PDF ↗ |
Product code HLT · Class II · Ophthalmic. Data: openFDA.