510(k) K012706
K012706 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "IM2001 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on March 7, 2003. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2003
- Date Received
- August 14, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type