510(k) K930786
K930786 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "EPCOR". The FDA issued a decision of Substantially Equivalent on September 26, 1994. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1994
- Date Received
- February 16, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Lead Switching, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2350
- Review Panel
- CV
- Submission Type