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FDA 510(k)

LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL

K-Number: K870173 · 1987-04-03

ApplicantMauna Loa Medical, Inc.
Decision Date1987-04-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Loa Medical, Inc.. It received FDA 510(k) clearance on 1987-04-03 under 510(k) number K870173. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL?

LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL is a medical device that received FDA 510(k) clearance on 1987-04-03. The listed applicant is Mauna Loa Medical, Inc.. The 510(k) number is K870173.

When did LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL receive FDA 510(k) clearance?

LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL received FDA 510(k) clearance on 1987-04-03, under 510(k) number K870173.

Who is the listed applicant for LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL?

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

What is the FDA product code for LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL?

The FDA product code for LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL is BTT.

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Other records listing Mauna Loa Medical, 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.

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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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