FDA applicant
Enteron, Inc.
FDA records 1 decision for Enteron, Inc. (Camp Hill, PA) in 1988: 1 510(k) clearance. All are in product code NRH (System, Breath Measurement). 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 Enteron, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Enteron, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Enteron, 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