Who is the manufacturer of LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060?

Graham-Field, Inc. filed the 510(k) submission for LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 (K961857).

What is the FDA product code for LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060?

Littmann Brand Electronic Stethoscope (K771653).

Who can help prepare an FDA 510(k) submission like LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060

K961857 · Graham-Field, Inc. · DQD · Jul 3, 1996 · Cardiovascular

Device Facts

Record ID	K961857
Device Name	LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
Applicant	Graham-Field, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Jul 3, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2

Intended Use

For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.

Device Story

Electronic stethoscope; amplifies internal body sounds (heart, arteries, veins, organs). Operation: user presses/holds button on diaphragm housing to activate; features volume control and two-position frequency response switch. Input: acoustic signals captured via electrostatic microphone. Output: amplified audio for clinician auscultation. Used in clinical settings by healthcare professionals. Enhances sound detection for diagnostic decision-making.

Clinical Evidence

No clinical data.

Technological Characteristics

Electronic stethoscope; electrostatic microphone; 4 alkaline manganese batteries; volume control; two-position frequency response switch; electronics housed in chest piece.

Indications for Use

Indicated for clinicians to project and amplify sounds associated with heart, arteries, veins, and other internal organs for diagnostic auscultation.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Littmann Brand Electronic Stethoscope (K771653)

Related Devices

K012304 — ADC 656 ELECTRONIC STETHOSCOPE · American Diagnostic Corp. · Nov 1, 2001
K961848 — 3M LITTMANN ELECTRONIC STETHOSCOPE · Minnesota Mining and Mfg. Co. · Sep 26, 1997
K082771 — PROTRON TECHNOLOGIES, LLC STETHOTRON · Protron Technologies, LLC · Feb 27, 2009
K050159 — MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 · 3M Company · Feb 22, 2005
K162589 — Adscope 658 Electronic Stethoscope · American Diagnostic Corp. · Mar 10, 2017

Submission Summary (Full Text)

{0} K961857 JUL - 3 1996 EXHIBIT #1 Page 1 of 2 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K961857. 1. **Submitter’s Identification:** Ms. Carol Bergh VP Regulatory Affairs Graham-Field, Inc. 400 Rabro Drive East Hauppauge, NY 11788 Date Summary Prepared: May 6, 1996 2. **Name of the Device:** Labtron Electromax Electronic Stethoscope 3. **Predicate Device Information:** Littmann Brand Electronic Stethoscope 510(k) #K771653, 3M Company, St. Paul, Minnesota 4. **Device Description:** This electronic stethoscope electronically amplifies sound with fingertip control; it is turned on by pressing and holding a button on the back of the diaphragm housing. The stethoscope has a volume control and a two position frequency response switch. 5. **Intended Use:** For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device. {1} EXHIBIT #1 Page 2 of 2 6. **Comparison to Predicate Devices:** Basic design is comparable in both operation and functionality, with the following differences: the Labtron electronically amplifies sound; the Littmann uses 2 silver oxide batteries vs. the Labtron utilizing 4 alkaline manganese batteries, frequency ranges for the Littmann is 20-200 Hz; the Labtron has an electrostatic microphone and only the Littmann has speaker in tubing vs. both having electronics in the chest piece. 7. **Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:** Testing information demonstrating safety and effectiveness of the Labtron Electromax device in the intended environment of use is supported by testing conducted in accordance with FDA’s guidelines "Reviewer Guidance for PMN Submissions", DCRND outlining electrical, mechanical and environmental performance standards. 8. **Discussion of Clinical Tests Performed:** Non-Applicable 9. **Conclusions:** Based upon the aforementioned information, the Labtron Electromax Electronic Stethoscope is substantially equivalent to the 3H Littmann Brand Electronic Stethoscope, and, safety and effectiveness have been established.