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FDA 510(k)

CRISTOBAL

K-Number: K980018 · 1998-05-19

ApplicantNewave Medical, Inc.
Decision Date1998-05-19
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRISTOBAL is the device name listed in this FDA 510(k) record. The listed applicant is Newave Medical, Inc.. It received FDA 510(k) clearance on 1998-05-19 under 510(k) number K980018. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRISTOBAL?

CRISTOBAL is a medical device that received FDA 510(k) clearance on 1998-05-19. The listed applicant is Newave Medical, Inc.. The 510(k) number is K980018.

When did CRISTOBAL receive FDA 510(k) clearance?

CRISTOBAL received FDA 510(k) clearance on 1998-05-19, under 510(k) number K980018.

Who is the listed applicant for CRISTOBAL?

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

What is the FDA product code for CRISTOBAL?

The FDA product code for CRISTOBAL is EBF.

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Related Devices (Code: EBF)

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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