FDA applicant
Brattle Instrument Corp.
FDA records 7 decisions for Brattle Instrument Corp. (Mchenry, IL) from 1977 to 1981: 7 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and KLK (Monitor, Oxygen, Cutaneous, For Infant Not…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brattle Instrument Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Brattle Instrument Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Brattle Instrument Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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