510(k) K022667
K022667 is an FDA 510(k) premarket notification submitted by Health Care Mfg., Inc. for the device "HCMI X-RAY". The FDA issued a decision of Substantially Equivalent on October 22, 2002. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Health Care Mfg., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2002
- Date Received
- August 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type