510(k) K052544
K052544 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "PULSE OXIMETER ADAPTER CABLES". The FDA issued a decision of Substantially Equivalent on September 29, 2006. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2006
- Date Received
- September 15, 2005
- Clearance Type
- Abbreviated
- 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