The following data is part of a premarket notification filed by Accutron, Inc. with the FDA for Rfs Vacuum Gauge Scavenging Circuit.
Device ID | K033503 |
510k Number | K033503 |
Device Name: | RFS VACUUM GAUGE SCAVENGING CIRCUIT |
Classification | Apparatus, Gas-scavenging |
Applicant | ACCUTRON, INC. 13605 WEST 7TH AVENUE Golden, CO 80401 -4604 |
Contact | Robert N Clark |
Correspondent | Robert N Clark ACCUTRON, INC. 13605 WEST 7TH AVENUE Golden, CO 80401 -4604 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-05 |
Decision Date | 2004-03-12 |
Summary: | summary |