The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Breathing Circuit Bacterial Filter.
| Device ID | K973797 |
| 510k Number | K973797 |
| Device Name: | BREATHING CIRCUIT BACTERIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Bruce E Green |
| Correspondent | Bruce E Green KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1998-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942122516 | K973797 | 000 |