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FDA 510(k)

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

K-Number: K861845 · 1986-08-11

ApplicantDirected Energy, Inc.
Decision Date1986-08-11
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1986-08-11 under 510(k) number K861845. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE?

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE is a medical device that received FDA 510(k) clearance on 1986-08-11. The listed applicant is Directed Energy, Inc.. The 510(k) number is K861845.

When did MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE receive FDA 510(k) clearance?

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE received FDA 510(k) clearance on 1986-08-11, under 510(k) number K861845.

Who is the listed applicant for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE?

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

What is the FDA product code for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE?

The FDA product code for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE is HHR.

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Other records listing Directed Energy, Inc. as applicant

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Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, 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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