The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Tri-med Model 105 Special Airway Adaptor.
| Device ID | K850747 |
| 510k Number | K850747 |
| Device Name: | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | TRI-MED, INC. 10301 WILLOWS RD. Redmond, WA 98005 |
| Contact | Bert Post |
| Correspondent | Bert Post TRI-MED, INC. 10301 WILLOWS RD. Redmond, WA 98005 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517053979 | K850747 | 000 |
| 35019517053658 | K850747 | 000 |
| 35019517053610 | K850747 | 000 |