Cleared Traditional

K841489 - NORELCO ELECTRONIC DIGITAL BP METER

K841489 · North American Philips Corp. · Cardiovascular device
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Apr 1984
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K841489 is an FDA 510(k) clearance for the NORELCO ELECTRONIC DIGITAL BP METER.

Submitted by North American Philips Corp. (Walker, US). The FDA issued a Cleared decision on April 10, 1984.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K841489

510(k) Number K841489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 10, 1984
Decision Date April 10, 1984
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -