The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Mk 808 Series Nasal Oxygen Sampler.
| Device ID | K822608 |
| 510k Number | K822608 |
| Device Name: | MK 808 SERIES NASAL OXYGEN SAMPLER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-30 |
| Decision Date | 1982-10-04 |