510(k) K082242
K082242 is an FDA 510(k) premarket notification submitted by Osypka Medical, Inc. for the device "ICON, MODEL C3". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Osypka Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2008
- Date Received
- August 7, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type