FDA 510(k)

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469

K-Number: K032789 · 2003-10-09

Decision Date2003-10-09

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 is the device name listed in this FDA 510(k) record. The listed applicant is American I.V. Products, Inc.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032789. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469?

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is American I.V. Products, Inc.. The 510(k) number is K032789.

When did REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 receive FDA 510(k) clearance?

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032789.

Who is the listed applicant for REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469?

The FDA 510(k) record lists American I.V. Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469?

The FDA product code for REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 is FRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.