HME-BOOSTER

Humidifier, Respiratory Gas, (direct Patient Interface)

KING SYSTEMS CORP.

The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Hme-booster.

Pre-market Notification Details

• Device ID: K990614
• 510k Number: K990614
• Device Name: HME-BOOSTER
• Classification: Humidifier, Respiratory Gas, (direct Patient Interface)
• Applicant: KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060
• Contact: Charles A Burt
• Correspondent: Charles A Burt; KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060
• Product Code: BTT
• CFR Regulation Number: 868.5450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-25
• Decision Date: 2000-05-23