The following data is part of a premarket notification filed by Brattle Instrument Corp. with the FDA for Transcutaneous Blood Oxygen Monitor #300.
| Device ID | K802978 |
| 510k Number | K802978 |
| Device Name: | TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | BRATTLE INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-21 |
| Decision Date | 1981-02-02 |