510(k) K830326
K830326 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "NEGATIVE PRESSURE ARTERIAL BLOOD LINE". The FDA issued a decision of Substantially Equivalent on February 28, 1983. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Erika, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1983
- Date Received
- February 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type