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 |