The following data is part of a premarket notification filed by Atlantis Scientific Corp. with the FDA for Asc 4080 System.
| Device ID | K843634 |
| 510k Number | K843634 |
| Device Name: | ASC 4080 SYSTEM |
| Classification | Transducer, Miniature Pressure |
| Applicant | ATLANTIS SCIENTIFIC CORP. 4377 W 96TH ST. Indianapolis, IN 46268 |
| Contact | Larry W Denney |
| Correspondent | Larry W Denney ATLANTIS SCIENTIFIC CORP. 4377 W 96TH ST. Indianapolis, IN 46268 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-11-08 |