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FDA 510(k)

ANALGESIA UNITS, OXYGEN & NITRATE DEVICE

K-Number: K800801 · 1980-05-28

ApplicantSpica, Inc.
Decision Date1980-05-28
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANALGESIA UNITS, OXYGEN & NITRATE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spica, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800801. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALGESIA UNITS, OXYGEN & NITRATE DEVICE?

ANALGESIA UNITS, OXYGEN & NITRATE DEVICE is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Spica, Inc.. The 510(k) number is K800801.

When did ANALGESIA UNITS, OXYGEN & NITRATE DEVICE receive FDA 510(k) clearance?

ANALGESIA UNITS, OXYGEN & NITRATE DEVICE received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800801.

Who is the listed applicant for ANALGESIA UNITS, OXYGEN & NITRATE DEVICE?

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

What is the FDA product code for ANALGESIA UNITS, OXYGEN & NITRATE DEVICE?

The FDA product code for ANALGESIA UNITS, OXYGEN & NITRATE DEVICE is BSZ.

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 Spica, Inc. 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.

K780365OXYGEN/NITROUS OXIDE OUTLETK780364MANIFOLD KIT

Related Devices (Code: BSZ)

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.

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

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