The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Edd.
| Device ID | K924997 |
| 510k Number | K924997 |
| Device Name: | EDD |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | ARC MEDICAL, INC. 735 PARK NORTH BLVD. BLDG 126 Clarkston, GA 30021 |
| Contact | Hal Norris |
| Correspondent | Hal Norris ARC MEDICAL, INC. 735 PARK NORTH BLVD. BLDG 126 Clarkston, GA 30021 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1995-03-28 |