The following data is part of a premarket notification filed by Enteron, Inc. with the FDA for Jayco Hydrogen Monitor.
| Device ID | K882499 |
| 510k Number | K882499 |
| Device Name: | JAYCO HYDROGEN MONITOR |
| Classification | System, Breath Measurement |
| Applicant | ENTERON, INC. 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Susan P Bjorkman |
| Correspondent | Susan P Bjorkman ENTERON, INC. 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | NRH |
| CFR Regulation Number | 862.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-17 |
| Decision Date | 1988-06-28 |