The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Ms-303-oxygen Regulator Shield.
| Device ID | K810679 |
| 510k Number | K810679 |
| Device Name: | MS-303-OXYGEN REGULATOR SHIELD |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-13 |
| Decision Date | 1981-04-17 |