The following data is part of a premarket notification filed by Sunox, Inc. with the FDA for Calibration Gas.
| Device ID | K944998 |
| 510k Number | K944998 |
| Device Name: | CALIBRATION GAS |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | SUNOX, INC. 4236 STATESVILLE RD. Charlotte, NC 28269 |
| Contact | Mark Daidone |
| Correspondent | Mark Daidone SUNOX, INC. 4236 STATESVILLE RD. Charlotte, NC 28269 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1995-02-03 |