The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Systems Corp. Universal F Breathing Circuit.
| Device ID | K922789 |
| 510k Number | K922789 |
| Device Name: | KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Michael A Leagre |
| Correspondent | Michael A Leagre KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1993-05-26 |