510(k) K841858
K841858 is an FDA 510(k) premarket notification submitted by Datamed, Inc. for the device "SPIROLOOP". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code BSE (Analyzer, Gas, Helium, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1640. Datamed, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1984
- Date Received
- May 4, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Helium, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1640
- Review Panel
- AN
- Submission Type