510(k) K033614
K033614 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215". The FDA issued a decision of Substantially Equivalent on July 29, 2004. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2004
- Date Received
- November 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type