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)

Submission Summary (Full Text)

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K961857

JUL - 3 1996

EXHIBIT #1
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# 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.

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EXHIBIT #1
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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.