510(k) K781386
K781386 is an FDA 510(k) premarket notification submitted by Equilibrated Bio Systems, Inc. for the device "EBS 775 TONOMETER". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical), a Class I device regulated under 21 CFR 862.1660. Equilibrated Bio Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1978
- Date Received
- August 11, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type