The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Nasogastric Voicetube.
| Device ID | K871632 |
| 510k Number | K871632 |
| Device Name: | NASOGASTRIC VOICETUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Contact | George G Siposs |
| Correspondent | George G Siposs AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-09-16 |