The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Aerosol Inhalation Monitor.
| Device ID | K893665 |
| 510k Number | K893665 |
| Device Name: | AEROSOL INHALATION MONITOR |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Lovina G Freeman |
| Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35099169457394 | K893665 | 000 |
| 35099169457387 | K893665 | 000 |
| 05099169457379 | K893665 | 000 |
| 05099169457355 | K893665 | 000 |
| 35099169457349 | K893665 | 000 |
| 35099169457332 | K893665 | 000 |
| 35099169457325 | K893665 | 000 |
| 35099169457103 | K893665 | 000 |
| 05099169331884 | K893665 | 000 |