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FDA 510(k)

OPPORTUNITY I.V. START KIT

K-Number: K971093 · 1997-09-16

ApplicantOpportunity, Inc.
Decision Date1997-09-16
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPPORTUNITY I.V. START KIT is the device name listed in this FDA 510(k) record. The listed applicant is Opportunity, Inc.. It received FDA 510(k) clearance on 1997-09-16 under 510(k) number K971093. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPPORTUNITY I.V. START KIT?

OPPORTUNITY I.V. START KIT is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Opportunity, Inc.. The 510(k) number is K971093.

When did OPPORTUNITY I.V. START KIT receive FDA 510(k) clearance?

OPPORTUNITY I.V. START KIT received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971093.

Who is the listed applicant for OPPORTUNITY I.V. START KIT?

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

What is the FDA product code for OPPORTUNITY I.V. START KIT?

The FDA product code for OPPORTUNITY I.V. START KIT is MGP.

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 Opportunity, 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.

K971091OPPURTUNITY TRACHEOSTOMY CARE KITK971089OPPORTUNITY, INC. LACERATION TRAYK971088OPPORTUNITY INCISION AND DRAINAGE TRAYK971090OPPORTUNITY DRESSING CHANGE TRAYK971095OPPORTUNITY SUTURE REMOVAL KITK971061OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

View all 8 devices →

Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, 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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