FDA 510(k)

SPS 550-IPS (INTEGRATED PATIENT STATION)

K-Number: K901038 · 1990-04-19

Decision Date1990-04-19

Product CodeFIL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SPS 550-IPS (INTEGRATED PATIENT STATION) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K901038. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPS 550-IPS (INTEGRATED PATIENT STATION)?

SPS 550-IPS (INTEGRATED PATIENT STATION) is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K901038.

When did SPS 550-IPS (INTEGRATED PATIENT STATION) receive FDA 510(k) clearance?

SPS 550-IPS (INTEGRATED PATIENT STATION) received FDA 510(k) clearance on 1990-04-19, under 510(k) number K901038.

Who is the listed applicant for SPS 550-IPS (INTEGRATED PATIENT STATION)?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPS 550-IPS (INTEGRATED PATIENT STATION)?

The FDA product code for SPS 550-IPS (INTEGRATED PATIENT STATION) is FIL. This falls under the Radiology category.

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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.