The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Respi-pak Rt-pak.
| Device ID | K910452 |
| 510k Number | K910452 |
| Device Name: | RESPI-PAK RT-PAK |
| Classification | Spirometer, Diagnostic |
| 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 | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-01 |
| Decision Date | 1991-04-16 |