510(k) K791811
K791811 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SPECTRUM AUTOMATIC CHEST UNIT MODEL C". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1979
- Date Received
- September 18, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Changer, Radiographic Film/Cassette
- Device Class
- Class II
- Regulation Number
- 892.1860
- Review Panel
- RA
- Submission Type