510(k) K862253
K862253 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL 482 CO-OXIMETER". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1986
- Date Received
- June 13, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Device Class
- Class I
- Regulation Number
- 862.3220
- Review Panel
- TX
- Submission Type