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FDA 510(k)

ISROBOT MONA LISA

K-Number: K111347 · 2011-08-12

ApplicantBiobot Surgical Pte., Ltd.
Decision Date2011-08-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISROBOT MONA LISA is the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2011-08-12 under 510(k) number K111347. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISROBOT MONA LISA?

ISROBOT MONA LISA is a medical device that received FDA 510(k) clearance on 2011-08-12. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K111347.

When did ISROBOT MONA LISA receive FDA 510(k) clearance?

ISROBOT MONA LISA received FDA 510(k) clearance on 2011-08-12, under 510(k) number K111347.

Who is the listed applicant for ISROBOT MONA LISA?

The FDA 510(k) record lists Biobot Surgical Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISROBOT MONA LISA?

The FDA product code for ISROBOT MONA LISA is IYO.

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Other records listing Biobot Surgical Pte., Ltd. 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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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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