The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Laryngoscope Attachment Ph2000.
| Device ID | K831255 |
| 510k Number | K831255 |
| Device Name: | LARYNGOSCOPE ATTACHMENT PH2000 |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | EDER INSTRUMENT CO, INC. 735 NORTH WATER ST. SUITE 1102 Milwaukee, Wi 53202, 53202 |
| Product Code | EQN |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-18 |
| Decision Date | 1983-09-12 |