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FDA 510(k)

BABYSET TM & PAC TM -PULMONARY ASSIST

K-Number: K841264 · 1984-06-15

ApplicantLife Design Systems, Inc.
Decision Date1984-06-15
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABYSET TM & PAC TM -PULMONARY ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1984-06-15 under 510(k) number K841264. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYSET TM & PAC TM -PULMONARY ASSIST?

BABYSET TM & PAC TM -PULMONARY ASSIST is a medical device that received FDA 510(k) clearance on 1984-06-15. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K841264.

When did BABYSET TM & PAC TM -PULMONARY ASSIST receive FDA 510(k) clearance?

BABYSET TM & PAC TM -PULMONARY ASSIST received FDA 510(k) clearance on 1984-06-15, under 510(k) number K841264.

Who is the listed applicant for BABYSET TM & PAC TM -PULMONARY ASSIST?

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

What is the FDA product code for BABYSET TM & PAC TM -PULMONARY ASSIST?

The FDA product code for BABYSET TM & PAC TM -PULMONARY ASSIST is CAI.

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Other records listing Life Design Systems, 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.

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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