The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Ptt-200 Pulmonary Receiver/microproces.
Device ID | K812850 |
510k Number | K812850 |
Device Name: | PTT-200 PULMONARY RECEIVER/MICROPROCES |
Classification | Calculator, Predicted Values, Pulmonary Function |
Applicant | PHARMAQUEST CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTY |
CFR Regulation Number | 868.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-09 |
Decision Date | 1981-12-03 |