The following data is part of a premarket notification filed by Portable Ophthalmic Devices, Inc. with the FDA for Pod Pac-20m.
| Device ID | K030610 |
| 510k Number | K030610 |
| Device Name: | POD PAC-20M |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PORTABLE OPHTHALMIC DEVICES, INC. 4413 WINSTON PLACE Bettendorf, IA 52722 |
| Contact | Tim Ehrecke |
| Correspondent | Tim Ehrecke PORTABLE OPHTHALMIC DEVICES, INC. 4413 WINSTON PLACE Bettendorf, IA 52722 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559011228 | K030610 | 000 |