510(k) Report

FDA applicant

Rigel Medical Electronics, Inc.

Mill Valley, CA6 decisions1984–19890 recalls

FDA records 6 decisions for Rigel Medical Electronics, Inc. (Mill Valley, CA) from 1984 to 1989: 6 510(k) clearances. All are in product code DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Rigel Medical Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rigel Medical Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rigel Medical Electronics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rigel Medical Electronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report