510(k) K780538
K780538 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "AUDIO MONITOR-MODEL 8309". The FDA issued a decision of Substantially Equivalent on April 19, 1978. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1978
- Date Received
- April 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conditioner, Signal, Physiological
- Device Class
- Class II
- Regulation Number
- 882.1845
- Review Panel
- NE
- Submission Type