The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Poly G Physiological Data Recorder.
| Device ID | K897107 |
| 510k Number | K897107 |
| Device Name: | POLY G PHYSIOLOGICAL DATA RECORDER |
| Classification | Transducer, Gas Pressure |
| Applicant | CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
| Contact | John F Stolte |
| Correspondent | John F Stolte CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
| Product Code | BXO |
| CFR Regulation Number | 868.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-03-12 |