The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for He Test.
| Device ID | K843843 |
| 510k Number | K843843 |
| Device Name: | HE TEST |
| Classification | Analyzer, Gas, Helium, Gaseous-phase |
| Applicant | ERICH JAEGER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSE |
| CFR Regulation Number | 868.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1984-12-04 |