510(k) K874327
K874327 is an FDA 510(k) premarket notification submitted by Marquette Electronics, Inc. for the device "SKIN PREP ANALYZER". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. Marquette Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1987
- Date Received
- October 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Electrode, Surface, Electrocardiographic
- Device Class
- Class II
- Regulation Number
- 870.2370
- Review Panel
- CV
- Submission Type