The following data is part of a premarket notification filed by Aerosport, Inc. with the FDA for Teen 100.
| Device ID | K945213 |
| 510k Number | K945213 |
| Device Name: | TEEN 100 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | AEROSPORT, INC. 3518 WEST LIBERTY ST. Ann Arbor, MI 48103 |
| Contact | Andrew Raeder |
| Correspondent | Andrew Raeder AEROSPORT, INC. 3518 WEST LIBERTY ST. Ann Arbor, MI 48103 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1995-05-25 |