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FDA 510(k)

E-SAN BLUETOOTH CRADLE

K-Number: K052343 · 2005-12-07

ApplicantE-San Limited
Decision Date2005-12-07
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

E-SAN BLUETOOTH CRADLE is the device name listed in this FDA 510(k) record. The listed applicant is E-San Limited. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K052343. 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 E-SAN BLUETOOTH CRADLE?

E-SAN BLUETOOTH CRADLE is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is E-San Limited. The 510(k) number is K052343.

When did E-SAN BLUETOOTH CRADLE receive FDA 510(k) clearance?

E-SAN BLUETOOTH CRADLE received FDA 510(k) clearance on 2005-12-07, under 510(k) number K052343.

Who is the listed applicant for E-SAN BLUETOOTH CRADLE?

The FDA 510(k) record lists E-San Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-SAN BLUETOOTH CRADLE?

The FDA product code for E-SAN BLUETOOTH CRADLE is NBW. This falls under the OB/GYN category.

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Other records listing E-San Limited 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.

K061328THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)

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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

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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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