The following data is part of a premarket notification filed by Fraser Sweatman, Inc. with the FDA for Pre-set 50/50 Nitrous Oxide/oxygen Mixer.
| Device ID | K760766 |
| 510k Number | K760766 |
| Device Name: | PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | FRASER SWEATMAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-04 |
| Decision Date | 1976-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816711020387 | K760766 | 000 |
| 00816711020370 | K760766 | 000 |