510(k) K912249
K912249 is an FDA 510(k) premarket notification submitted by Theta Systems, Inc. for the device "PATIENT DOSE MONITOR". The FDA issued a decision of Substantially Equivalent on August 30, 1991. The device falls under product code KPZ (Generator, High Voltage, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Theta Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1991
- Date Received
- May 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, High Voltage, X-Ray, Therapeutic
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type