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FDA 510(k)

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM

K-Number: K922757 · 1995-02-13

ApplicantBaxter Healthcare Corp
Decision Date1995-02-13
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM 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 1995-02-13 under 510(k) number K922757. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPS 1550 SINGLE NEEDLE PATIENT SYSTEM?

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K922757.

When did SPS 1550 SINGLE NEEDLE PATIENT SYSTEM receive FDA 510(k) clearance?

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM received FDA 510(k) clearance on 1995-02-13, under 510(k) number K922757.

Who is the listed applicant for SPS 1550 SINGLE NEEDLE PATIENT SYSTEM?

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 1550 SINGLE NEEDLE PATIENT SYSTEM?

The FDA product code for SPS 1550 SINGLE NEEDLE PATIENT SYSTEM is FKP.

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Other records listing Baxter Healthcare Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

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Related Devices (Code: FKP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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.

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