510(k) K873956
K873956 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "ULTIMETER". The FDA issued a decision of Substantially Equivalent on October 30, 1987. The device falls under product code LHO (Instrument, Quality-Assurance, Radiologic), a Class I device regulated under 21 CFR 892.1940. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1987
- Date Received
- September 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Quality-Assurance, Radiologic
- Device Class
- Class I
- Regulation Number
- 892.1940
- Review Panel
- RA
- Submission Type