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FDA 510(k)

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC

K-Number: K012262 · 2001-09-12

ApplicantNational Custom Ent., Inc.
Decision Date2001-09-12
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC is the device name listed in this FDA 510(k) record. The listed applicant is National Custom Ent., Inc.. It received FDA 510(k) clearance on 2001-09-12 under 510(k) number K012262. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC?

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC is a medical device that received FDA 510(k) clearance on 2001-09-12. The listed applicant is National Custom Ent., Inc.. The 510(k) number is K012262.

When did BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC receive FDA 510(k) clearance?

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC received FDA 510(k) clearance on 2001-09-12, under 510(k) number K012262.

Who is the listed applicant for BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC?

The FDA 510(k) record lists National Custom Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC?

The FDA product code for BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC is MRZ.

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Other records listing National Custom Ent., Inc. 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.

K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWCK012266SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2K012259MEDFUSION 2001 & 2010, MODEL N7215IWCK012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WCK943632REPLACEMENT BATTERIES

View all 12 devices →

Related Devices (Code: MRZ)

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.

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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.

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