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510(k) Data Aggregation
K Number
K955477Device Name
HI-TEC CO2 INSUFFLATOR TYPE 1300Date Cleared
1997-08-06
(615 days)
Product Code
Regulation Number
884.1730Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
CO2 Laparoscopic Insufflator type 1300
AI/ML Overview
The provided document is a 510(k) clearance letter from the FDA for a CO2 Laparoscopic Insufflator. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot answer the request based on the provided input.
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