The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Laser - 1000.
| Device ID | K882436 |
| 510k Number | K882436 |
| Device Name: | LASER - 1000 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PANORAMIC CORP. 4321 GOSHEN RD. Fort Wayne, IN 46818 |
| Contact | Eric J Stetzel |
| Correspondent | Eric J Stetzel PANORAMIC CORP. 4321 GOSHEN RD. Fort Wayne, IN 46818 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862309000316 | K882436 | 000 |