510(k) K841733
K841733 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO WASTE GAS SCAVENGING RESERVOIR". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Ohio Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1984
- Date Received
- April 26, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Gas-Scavenging
- Device Class
- Class II
- Regulation Number
- 868.5430
- Review Panel
- AN
- Submission Type