Source: Third-party index, not matched to FDA. This record came from a third-party Form 483 index rather than from FDA directly, and we have not been able to match it to a document or an inspection FDA publishes. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI N/A.
ObservationsNot available
Issue DateOctober 12, 2023
StatusWarning Letter Issued
Related Inspections0
Establishment Details
Firm
Various Pulse Oximeter Manufacturers
Location
United States
FEI Number
N/A
Issue Date
October 12, 2023
Country
United States
Inspection History
We hold no FDA inspection matched to this establishment.