The following data is part of a premarket notification filed by Medisize Bv with the FDA for Medisize Blue, Medisize Green, Medisize Red.
| Device ID | K081536 |
| 510k Number | K081536 |
| Device Name: | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MEDISIZE BV EDISONSTRAAT 1 Hillegom, NL 2181 Ab |
| Correspondent | Harry J Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2009-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788777151 | K081536 | 000 |
| 05055788778219 | K081536 | 000 |
| 05055788778202 | K081536 | 000 |
| 05055788778196 | K081536 | 000 |
| 05055788778233 | K081536 | 000 |
| 05055788778226 | K081536 | 000 |
| 05055788778189 | K081536 | 000 |
| 05055788778172 | K081536 | 000 |
| 05055788778165 | K081536 | 000 |
| 05055788792031 | K081536 | 000 |
| 05055788792048 | K081536 | 000 |
| 05055788792161 | K081536 | 000 |
| 05055788792154 | K081536 | 000 |
| 05055788792147 | K081536 | 000 |
| 05055788792130 | K081536 | 000 |
| 05055788792086 | K081536 | 000 |
| 05055788792079 | K081536 | 000 |
| 05055788792062 | K081536 | 000 |
| 05055788792055 | K081536 | 000 |
| 05055931103868 | K081536 | 000 |