The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Systems, Disp. Anesthesia Breathing Circuit.
Device ID | K880683 |
510k Number | K880683 |
Device Name: | KING SYSTEMS, DISP. ANESTHESIA 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 | Linda L Nordlund |
Correspondent | Linda L Nordlund 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 | 1988-02-19 |
Decision Date | 1988-03-09 |