510(k) K062155
K062155 is an FDA 510(k) premarket notification submitted by Porter Instrument Co., Inc. for the device "DIGITAL MXR-D FLOWMETER". The FDA issued a decision of Substantially Equivalent on November 9, 2006. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Porter Instrument Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2006
- Date Received
- July 28, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type