The following data is part of a premarket notification filed by Innomed Technologies Inc./respcare Inc. with the FDA for Respcare Hybrid Ne Face Mask, Model Tbd,; Disposable, Model Tbd.
Device ID | K062019 |
510k Number | K062019 |
Device Name: | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD |
Classification | Ventilator, Continuous, Facility Use |
Applicant | INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073 |
Contact | Frank Pelc |
Correspondent | Frank Pelc INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek, FL 33073 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-17 |
Decision Date | 2006-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10607411945738 | K062019 | 000 |
10607411943789 | K062019 | 000 |
10607411943796 | K062019 | 000 |
10607411943802 | K062019 | 000 |
10607411943819 | K062019 | 000 |
10607411943826 | K062019 | 000 |
10607411945622 | K062019 | 000 |
10607411945639 | K062019 | 000 |
10607411945646 | K062019 | 000 |
10607411945653 | K062019 | 000 |
10607411945660 | K062019 | 000 |
10607411945677 | K062019 | 000 |
10607411945714 | K062019 | 000 |
10607411945721 | K062019 | 000 |
10607411943772 | K062019 | 000 |