The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Sh-1.
| Device ID | K770344 |
| 510k Number | K770344 |
| Device Name: | SH-1 |
| Classification | Apparatus, Gas-scavenging |
| Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-02-18 |
| Decision Date | 1977-05-09 |