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FDA 510(k)

EMC MODEL NO. STATOME 900

K-Number: K911353 · 1991-06-24

ApplicantEmc Industries
Decision Date1991-06-24
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMC MODEL NO. STATOME 900 is the device name listed in this FDA 510(k) record. The listed applicant is Emc Industries. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911353. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMC MODEL NO. STATOME 900?

EMC MODEL NO. STATOME 900 is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Emc Industries. The 510(k) number is K911353.

When did EMC MODEL NO. STATOME 900 receive FDA 510(k) clearance?

EMC MODEL NO. STATOME 900 received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911353.

Who is the listed applicant for EMC MODEL NO. STATOME 900?

The FDA 510(k) record lists Emc Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMC MODEL NO. STATOME 900?

The FDA product code for EMC MODEL NO. STATOME 900 is HAM.

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 Emc Industries 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.

K952231EMC MODEL STATOME 200K941721EMC MODEL NO. 322870 ENDOSTAT

Related Devices (Code: HAM)

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.

K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.K945861BERGEN 710 ESUBergen Mfg.K913300LAPAROSTAT(TM)Cook Ob/GynK920100GSU HANDPIECE ADAPTERBeacon Laboratories, 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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