510(k) K904499
K904499 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)". The FDA issued a decision of Substantially Equivalent on July 1, 1991. The device falls under product code KFG (Antiserum, Positive Control, Aspergillus Spp.), a Class I device regulated under 21 CFR 866.3040. Ackrad Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1991
- Date Received
- October 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Positive Control, Aspergillus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3040
- Review Panel
- MI
- Submission Type