510(k) K780150
K780150 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "NEONATAL SCREENING AUDIOMETER". The FDA issued a decision of Substantially Equivalent on February 13, 1978. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1978
- Date Received
- January 30, 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