510(k) K841556
K841556 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "HEART - AID ALS, 95". The FDA issued a decision of Substantially Equivalent on July 19, 1984. The device falls under product code LDO (Enzymatic Radiochemical Assay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1984
- Date Received
- April 16, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Radiochemical Assay, Tobramycin
- Device Class
- Class II
- Regulation Number
- 862.3900
- Review Panel
- TX
- Submission Type