510(k) K971683
K971683 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET". The FDA issued a decision of Substantially Equivalent on October 22, 1997. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Marquette Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1997
- Date Received
- May 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type