The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for N20 Test.
| Device ID | K853360 |
| 510k Number | K853360 |
| Device Name: | N20 TEST |
| Classification | Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) |
| Applicant | ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Contact | Ronald Evenson |
| Correspondent | Ronald Evenson ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Product Code | CBR |
| CFR Regulation Number | 868.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-09-03 |