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FDA 510(k)

SONDREX P.A.L. SYSTEM

K-Number: K010388 · 2001-12-11

ApplicantOhmeda Medical
Decision Date2001-12-11
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SONDREX P.A.L. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 2001-12-11 under 510(k) number K010388. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONDREX P.A.L. SYSTEM?

SONDREX P.A.L. SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-11. The listed applicant is Ohmeda Medical. The 510(k) number is K010388.

When did SONDREX P.A.L. SYSTEM receive FDA 510(k) clearance?

SONDREX P.A.L. SYSTEM received FDA 510(k) clearance on 2001-12-11, under 510(k) number K010388.

Who is the listed applicant for SONDREX P.A.L. SYSTEM?

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

What is the FDA product code for SONDREX P.A.L. SYSTEM?

The FDA product code for SONDREX P.A.L. SYSTEM is HCC.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

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Related Devices (Code: HCC)

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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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