510(k) K903307
K903307 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "TEMP MARQ TEMPERATURE TREND INDICATOR". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1990
- Date Received
- July 24, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Temperature, Forehead, Liquid Crystal
- Device Class
- Class II
- Regulation Number
- 880.2200
- Review Panel
- HO
- Submission Type