510(k) K881939
K881939 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIRECUST 1280/1281 & 960/961 PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1988
- Date Received
- May 9, 1988
- 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