510(k) K770115
K770115 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "ARTERIAL DIAGNOSTIC UNIT (ADU)". The FDA issued a decision of Substantially Equivalent on February 1, 1977. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Medical Electronic Devices, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1977
- Date Received
- January 19, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type