Biosensors Interventional Technologies Pte Ltd

Warning LetterOpen

Recipient Title Quality and Regulatory Affairs Director, Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang 619266 SingaporeIssued Jul 21, 2023OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateJul 21, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Biosensors Interventional Technologies Pte Ltd
Location: Recipient Title Quality and Regulatory Affairs Director, Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang 619266 Singapore
FEI Number: N/A
Country: Singapore
Issue Date: July 21, 2023
Issuing Office: OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality
Product Type: Medical Devices
Status: Open

Subject

Medical Device Reporting/Misbranded

Biosensors Interventional Technologies Pte Ltd FDA Warning Letter, July 21, 2023