The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Masterlab Pft And Masterlab Body Box.
| Device ID | K893420 |
| 510k Number | K893420 |
| Device Name: | MASTERLAB PFT AND MASTERLAB BODY BOX |
| Classification | Plethysmograph, Pressure |
| 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 | CCM |
| CFR Regulation Number | 868.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1989-06-23 |