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FDA 510(k)

PALCO LABS COLD POUCH

K-Number: K942810 · 1995-06-28

ApplicantPalco Laboratories, Inc.
Decision Date1995-06-28
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PALCO LABS COLD POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Palco Laboratories, Inc.. It received FDA 510(k) clearance on 1995-06-28 under 510(k) number K942810. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALCO LABS COLD POUCH?

PALCO LABS COLD POUCH is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is Palco Laboratories, Inc.. The 510(k) number is K942810.

When did PALCO LABS COLD POUCH receive FDA 510(k) clearance?

PALCO LABS COLD POUCH received FDA 510(k) clearance on 1995-06-28, under 510(k) number K942810.

Who is the listed applicant for PALCO LABS COLD POUCH?

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

What is the FDA product code for PALCO LABS COLD POUCH?

The FDA product code for PALCO LABS COLD POUCH is LDQ.

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Other records listing Palco Laboratories, 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.

K943842PULSE OXIMETER MODEL 305K920066PALCO LABS MODEL 340 PULSE OXIMETERK913694PALCO LABS LOADMATICK911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITORK904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITORK872233INJECT-EASE

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Related Devices (Code: LDQ)

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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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