The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Respichamber Valved Holding Chamber.
| Device ID | K110136 |
| 510k Number | K110136 |
| Device Name: | RESPICHAMBER VALVED HOLDING CHAMBER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Darryl Fisher |
| Correspondent | Darryl Fisher TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10762860001135 | K110136 | 000 |