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FDA 510(k)

SOMA SAFE ENCLOSURE

K-Number: K963701 · 1997-01-24

ApplicantNova Technology Corp.
Decision Date1997-01-24
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOMA SAFE ENCLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Nova Technology Corp.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K963701. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMA SAFE ENCLOSURE?

SOMA SAFE ENCLOSURE is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Nova Technology Corp.. The 510(k) number is K963701.

When did SOMA SAFE ENCLOSURE receive FDA 510(k) clearance?

SOMA SAFE ENCLOSURE received FDA 510(k) clearance on 1997-01-24, under 510(k) number K963701.

Who is the listed applicant for SOMA SAFE ENCLOSURE?

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

What is the FDA product code for SOMA SAFE ENCLOSURE?

The FDA product code for SOMA SAFE ENCLOSURE is FNL.

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 Nova Technology Corp. 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.

K964246NOVABED PATIENT TRANSFER SYSTEMK874448NOVA TRANSFER SYSTEM, MODEL XXX

Related Devices (Code: FNL)

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.

K202964iBed Wireless with iBed MobileStryker CorporationK103536IBED WIRELESS WITH IBED AWARENESSStryker CorporationK982783VAIL 1000 ENCLOSED BEDVail Products, Inc.K974296MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BEDInvacare Corp.K974254BENEFIT B3--- SERIESM.C. Healthcare Products, Inc.K972115VOLKER HOSPITAL BED, MODEL K960Volker Healthcare, 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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