510(k) K052489
K052489 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "ACTIHEART". The FDA issued a decision of Substantially Equivalent on September 27, 2005. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2005
- Date Received
- September 12, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Conditioner, Signal, Physiological
- Device Class
- Class II
- Regulation Number
- 882.1845
- Review Panel
- NE
- Submission Type