The following data is part of a premarket notification filed by Boehringer Ingelheim Pharmaceuticals, Inc. with the FDA for Inhalation Aid.
| Device ID | K863049 |
| 510k Number | K863049 |
| Device Name: | INHALATION AID |
| Classification | Mouthpiece, Breathing |
| Applicant | BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. 90 EAST RIDGE P.O. BOX 368 Ridgefield, CT 06877 |
| Contact | Ruth Wasserman |
| Correspondent | Ruth Wasserman BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. 90 EAST RIDGE P.O. BOX 368 Ridgefield, CT 06877 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-10-15 |