510(k) K851460
K851460 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA". The FDA issued a decision of Substantially Equivalent on May 10, 1985. The device falls under product code BXY (Flowmeter, Calibration, Gas), a Class I device regulated under 21 CFR 868.2350. Telectronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 1985
- Date Received
- April 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Calibration, Gas
- Device Class
- Class I
- Regulation Number
- 868.2350
- Review Panel
- AN
- Submission Type