← Product Code [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI) · K060781 # MEDICAL COMPRESSOR, MODELS DK50 D AND DM (K060781) _Ekom S.R.O. · BTI · Oct 3, 2006 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K060781 ## Device Facts - **Applicant:** Ekom S.R.O. - **Product Code:** [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI.md) - **Decision Date:** Oct 3, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.6250 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators. ## Device Story Electric medical compressor; produces compressed air from ambient environment; supplies air to medical ventilators. Used in clinical settings to support ventilator operation. Provides necessary pneumatic power for ventilation therapy. ## Clinical Evidence Bench testing only. Compliance with IEC 60601-1-2:2001 and EN 55011:1998 &A1:1999 standards. ## Technological Characteristics Electric medical compressor; operates by compressing ambient air. Tested to IEC 60601-1-2:2001 and EN 55011:1998 &A1:1999 standards. ## Regulatory Identification A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. ## Predicate Devices - Newport C250 Air Compressor ([K041406](/device/K041406.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K060781 OCT - 3 2006 DK50 D and DK50 DM Medical Compressors Traditional 510(k) # Section 3. 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### A. Name, Address, Phone and Fax Number of the Applicant EKOM s.r.o ЕКОМ Priemyselna 5031/18 921 01 Piestany Slovak Republic Tel: +421 33 7967255 Fax: +421 33 7967223 #### B. Contact Person Julius Ivan EKOM s.r.o Priemyselna 5031/18 921 01 Piestany Slovak Republic### C. Date Prepared March 3, 2006 #### D. Device Name Medical Compressors DK50 D and DK50 DM #### E. Device Description The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators. #### F. Device Intended Use The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators. {1}------------------------------------------------ ## G. Substantial Equivalence Summary The DK50 D and DK50 DM Medical Compressors are substantially equivalent in intended use, physical characteristics, performance, and safety characteristics to the Newport C250 Air Compressor, cleared under #K041406. #### H. Device Testing Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance with various industry recognized standards, including: IEC 60601-1-2:2001, EN 55011:1998 &A1:1999. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure. OCT - 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ekom S.R.O. C/O Ms. Esther Saltz Esther Saltz Regulatory Consulting 32884 Danapoplar Dana Point, California 92629 Re: K060781 Trade/Device Name: Medical Compressor, Models DK50 D and DK50 DM Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: September 11, 2006 Received: September 13, 2006 Dear Ms. Saltz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Ms. Saltz Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Appendix A. Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: The Medical Compressor Models DK50 D and DK50 DM Indications for Use: The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Posted November 13, 2003) Guy Salmon Ji) Sign-Cit) on of Anesthesiology, General Hospital. Jon Control, Dental Devices Number K060781 CONFIDENTIAL --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K060781](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K060781) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com