510(k) K853040
K853040 is an FDA 510(k) premarket notification submitted by Erie Medical for the device "PRESSURE GAUGE". The FDA issued a decision of Substantially Equivalent on October 10, 1985. The device falls under product code BXH (Gauge, Gas Pressure, Cylinder/Pipeline), a Class I device regulated under 21 CFR 868.2610. Erie Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1985
- Date Received
- July 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Gas Pressure, Cylinder/Pipeline
- Device Class
- Class I
- Regulation Number
- 868.2610
- Review Panel
- AN
- Submission Type