BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)

Filter, Bacterial, Breathing-circuit

KING SYSTEMS CORP.

The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Breathing Circuit Bacterial Filter/heat And Moisture Exchanger (hme/f).

Pre-market Notification Details

• Device ID: K983817
• 510k Number: K983817
• Device Name: BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
• Classification: Filter, Bacterial, Breathing-circuit
• 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: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-29
• Decision Date: 1999-03-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00612649151984	K983817	000
00612649181783	K983817	000
00612649181813	K983817	000
00612649140216	K983817	000
00612649181776	K983817	000
00612649141978	K983817	000