The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Laryngo-stroboscope Model Ls-1a.
| Device ID | K801866 |
| 510k Number | K801866 |
| Device Name: | PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A |
| Classification | Laryngostroboscope |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQL |
| CFR Regulation Number | 874.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-05 |
| Decision Date | 1980-09-16 |