The following data is part of a premarket notification filed by Pulmonary Data Services Inst., Inc. with the FDA for Koko Filter Ii.
| Device ID | K934475 |
| 510k Number | K934475 |
| Device Name: | KOKO FILTER II |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PULMONARY DATA SERVICES INST., INC. P.O. BOX 400 Louisville, CO 80027 |
| Contact | Fred Good |
| Correspondent | Fred Good PULMONARY DATA SERVICES INST., INC. P.O. BOX 400 Louisville, CO 80027 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1993-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852417003651 | K934475 | 000 |