510(k) K052063
K052063 is an FDA 510(k) premarket notification submitted by A & A Medical Supplies, Inc. for the device "HUANQIU HEATING LAMP". The FDA issued a decision of Substantially Equivalent on September 30, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. A & A Medical Supplies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2005
- Date Received
- July 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type