Stealthshield
FDA 510(k) K970755 · Vital Connections, Inc.
510(k) numberK970755
Submission
- Device name
- Stealthshield
- Applicant
- Vital Connections, Inc.
Tipp City, OH, US - Received
- March 3, 1997
- Decision date
- April 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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Questions and answers
When was Stealthshield cleared by the FDA?
Stealthshield (K970755) received a 510(k) decision of Substantially Equivalent on April 15, 1997, 43 days after the submission was received.
What is the product code of K970755?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.