510(k) K781474
K781474 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "PREAMPLIFIER MODELS 8101PI & 8102PI". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1978
- Date Received
- August 28, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type