The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Iso-gard Hepa Filter-hme, Iso-ard Hepa Filter-hme W/port.
| Device ID | K954828 |
| 510k Number | K954828 |
| Device Name: | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-20 |
| Decision Date | 1996-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704389061 | K954828 | 000 |
| 34026704929291 | K954828 | 000 |
| 24026704929324 | K954828 | 000 |
| 24026704929799 | K954828 | 000 |
| 34026704929819 | K954828 | 000 |
| 44026704348075 | K954828 | 000 |
| 24026704348088 | K954828 | 000 |
| 24026704348095 | K954828 | 000 |
| 24026704348125 | K954828 | 000 |
| 34026704929284 | K954828 | 000 |