The following data is part of a premarket notification filed by Vacumetrics, Inc. with the FDA for Vista Interface Sysstem.
Device ID | K860844 |
510k Number | K860844 |
Device Name: | VISTA INTERFACE SYSSTEM |
Classification | Calculator, Pulmonary Function Data |
Applicant | VACUMETRICS, INC. 2261 PALMA DR. Ventura, CA 93003 |
Contact | Ronald Thompson |
Correspondent | Ronald Thompson VACUMETRICS, INC. 2261 PALMA DR. Ventura, CA 93003 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-06 |
Decision Date | 1986-04-02 |