The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Handypack 911sc.
Device ID | K944541 |
510k Number | K944541 |
Device Name: | HANDYPACK 911SC |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
Contact | Ilhan Bilgutay |
Correspondent | Ilhan Bilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-15 |
Decision Date | 1995-02-22 |