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FDA 510(k)

ML-800 CO2

K-Number: K800227 · 1980-03-03

ApplicantMerrimack Laboratories
Decision Date1980-03-03
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ML-800 CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Merrimack Laboratories. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K800227. 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 ML-800 CO2?

ML-800 CO2 is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Merrimack Laboratories. The 510(k) number is K800227.

When did ML-800 CO2 receive FDA 510(k) clearance?

ML-800 CO2 received FDA 510(k) clearance on 1980-03-03, under 510(k) number K800227.

Who is the listed applicant for ML-800 CO2?

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

What is the FDA product code for ML-800 CO2?

The FDA product code for ML-800 CO2 is HHR.

Other records listing Merrimack Laboratories 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.

K833528CARBON DIOXIDE LASER ML 825K833483ENDOSCOPIC COUPLERK827963MODEL ML-850K827506MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERYK827442ML-810 CARBON DIOXIDE LASER SYSTEM

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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