The following data is part of a premarket notification filed by North Eos Industries, Inc. with the FDA for Eos Brand Disposable Proctoscope.
| Device ID | K954614 |
| 510k Number | K954614 |
| Device Name: | EOS BRAND DISPOSABLE PROCTOSCOPE |
| Classification | Endoscope, Ac-powered And Accessories |
| Applicant | NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH Taichung Hsien 423, TW |
| Contact | Sara Chen |
| Correspondent | Sara Chen NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH Taichung Hsien 423, TW |
| Product Code | GCP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-05 |
| Decision Date | 1996-04-10 |