The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q101 Diagnostic Spirometer.
| Device ID | K863300 |
| 510k Number | K863300 |
| Device Name: | Q101 DIAGNOSTIC SPIROMETER |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-11-13 |