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FDA 510(k)

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K

K-Number: K993387 · 1999-11-01

ApplicantBaxter Healthcare Corp
Decision Date1999-11-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K 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 1999-11-01 under 510(k) number K993387. 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 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K?

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K993387.

When did IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K receive FDA 510(k) clearance?

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K received FDA 510(k) clearance on 1999-11-01, under 510(k) number K993387.

Who is the listed applicant for IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K?

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 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K?

The FDA product code for IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K is FRN.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: FRN)

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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