510(k) K781289
K781289 is an FDA 510(k) premarket notification submitted by Princeton Applied Research Corp. for the device "PREAMPLIFIER MODEL 113". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Princeton Applied Research Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1978
- Date Received
- July 27, 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