510(k) K853190
K853190 is an FDA 510(k) premarket notification submitted by Cdx Corp. for the device "SUPERSPIRO". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Cdx Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1985
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type