510(k) K930134
K930134 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT". The FDA issued a decision of Substantially Equivalent on April 9, 1993. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. S & W Medico Teknik has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1993
- Date Received
- January 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type