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FDA 510(k)

DRTS IMAGE INTENSIFIER DRAPE

K-Number: K973073 · 1997-10-08

ApplicantMinrad, Inc.
Decision Date1997-10-08
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRTS IMAGE INTENSIFIER DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Minrad, Inc.. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K973073. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRTS IMAGE INTENSIFIER DRAPE?

DRTS IMAGE INTENSIFIER DRAPE is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Minrad, Inc.. The 510(k) number is K973073.

When did DRTS IMAGE INTENSIFIER DRAPE receive FDA 510(k) clearance?

DRTS IMAGE INTENSIFIER DRAPE received FDA 510(k) clearance on 1997-10-08, under 510(k) number K973073.

Who is the listed applicant for DRTS IMAGE INTENSIFIER DRAPE?

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

What is the FDA product code for DRTS IMAGE INTENSIFIER DRAPE?

The FDA product code for DRTS IMAGE INTENSIFIER DRAPE is JAA.

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Other records listing Minrad, 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.

K072255MINRAD INC. NASAL SCAVENGING CIRCUITK071814LIGHT SABRE SPINAL ACCESS DEVICEK062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002K062231MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001K041852MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002K041846SABRESOURCE DRAPE

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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