Calg-Str Exercise ECG Analysis Algorithm
FDA 510(k) K112959 · Philips Health Care
510(k) numberK112959
Submission
- Device name
- Calg-Str Exercise ECG Analysis Algorithm
- Applicant
- Philips Health Care
Thousand Oaks, CA, US - Received
- October 4, 2011
- Decision date
- January 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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Questions and answers
When was Calg-Str Exercise ECG Analysis Algorithm cleared by the FDA?
Calg-Str Exercise ECG Analysis Algorithm (K112959) received a 510(k) decision of Substantially Equivalent on January 26, 2012, 114 days after the submission was received.
What is the product code of K112959?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.