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FDA 510(k)

IDEAL LIFE POD (MODEL ILP 0001)

K-Number: K080538 · 2008-07-03

ApplicantIdeal Life, Inc.
Decision Date2008-07-03
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDEAL LIFE POD (MODEL ILP 0001) is the device name listed in this FDA 510(k) record. The listed applicant is Ideal Life, Inc.. It received FDA 510(k) clearance on 2008-07-03 under 510(k) number K080538. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDEAL LIFE POD (MODEL ILP 0001)?

IDEAL LIFE POD (MODEL ILP 0001) is a medical device that received FDA 510(k) clearance on 2008-07-03. The listed applicant is Ideal Life, Inc.. The 510(k) number is K080538.

When did IDEAL LIFE POD (MODEL ILP 0001) receive FDA 510(k) clearance?

IDEAL LIFE POD (MODEL ILP 0001) received FDA 510(k) clearance on 2008-07-03, under 510(k) number K080538.

Who is the listed applicant for IDEAL LIFE POD (MODEL ILP 0001)?

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

What is the FDA product code for IDEAL LIFE POD (MODEL ILP 0001)?

The FDA product code for IDEAL LIFE POD (MODEL ILP 0001) is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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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Other records listing Ideal Life, 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.

K060504IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001

Related Devices (Code: NBW)

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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