Dual Head Stethoscope

FDA 510(k) K791338 · Amdia Medical Products

Substantially Equivalent

510(k) numberK791338

Submission

Device name
Dual Head Stethoscope
Applicant
Amdia Medical Products
Mchenry, IL, US
Received
July 20, 1979
Decision date
August 10, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

Other 510(k)s with product code DQD

510(k)DeviceApplicantDecision
K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional Shanghai Hulu Devices Co., Ltd.07/31/2026SE
K261694CORE 300 Digital StethoscopeDQD · Traditional Eko Health, Inc.07/23/2026SE
K252915AiSteth®DQD · Traditional Ai Health Highway India Pvt., Ltd.05/22/2026SE
K252089Tyto Stethoscope (G3)DQD · Traditional Tyto Care , Ltd.03/12/2026SE
K252076Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional Kneevoice, Inc.02/06/2026SE
K252284eMurmur Heart AIDQD · Traditional Csd Labs12/19/2025SE
K252595Stethophone ProDQD · Special Sparrow Acoustics, Inc.09/12/2025SE
K251494Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional Eko Health, Inc.08/12/2025SE
K242971AccurSound Electronic Stethoscope (AS101)DQD · Traditional Heroic Faith International , Ltd.11/25/2024SE
K240901StethophoneDQD · Traditional Sparrow Acoustics, Inc.09/19/2024SE

More from Sparrow Acoustics, Inc.

510(k)DeviceDecision
K791335NursescopeDQD · Traditional 08/10/1979SE
K791334MultiscopeDQD · Traditional 08/10/1979SE
K791333Bowles StethoscopeDQD · Traditional 08/10/1979SE
K791337Taylor Neurological HammerGWZ · Traditional 08/03/1979SE
K791336Bucks Neurological HammerGWZ · Traditional 08/03/1979SE

Questions and answers

When was Dual Head Stethoscope cleared by the FDA?

Dual Head Stethoscope (K791338) received a 510(k) decision of Substantially Equivalent on August 10, 1979, 21 days after the submission was received.

What is the product code of K791338?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.