510(k) K781743
K781743 is an FDA 510(k) premarket notification submitted by Tracor Instruments, Inc. for the device "RESPONSE SYSTEM, TN-3000". The FDA issued a decision of Substantially Equivalent on Dec 1, 1978. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Tracor Instruments, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 1, 1978
- Date Received
- Oct 20, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type
- 510(k)