510(k) K771014
K771014 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "TS-100 TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 14, 1977. The device falls under product code KRC (Tester, Electrode, Surface, Electrocardiographic), a Class II device regulated under 21 CFR 870.2370. Delta Medical Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1977
- Date Received
- June 6, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Electrode, Surface, Electrocardiographic
- Device Class
- Class II
- Regulation Number
- 870.2370
- Review Panel
- CV
- Submission Type