510(k) K113216
K113216 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "RAPIDPOINT 500 BLOOD GAS ANALYER". The FDA issued a decision of Substantially Equivalent on May 3, 2012. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2012
- Date Received
- November 1, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Lactic, Enzymatic Method
- Device Class
- Class I
- Regulation Number
- 862.1450
- Review Panel
- CH
- Submission Type