Electro-Plethysmograph
FDA 510(k) K780761 · Biotecx Laboratories, Inc.
510(k) numberK780761
Submission
- Device name
- Electro-Plethysmograph
- Applicant
- Biotecx Laboratories, Inc.
Mchenry, IL, US - Received
- May 9, 1978
- Decision date
- June 30, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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Questions and answers
When was Electro-Plethysmograph cleared by the FDA?
Electro-Plethysmograph (K780761) received a 510(k) decision of Substantially Equivalent on June 30, 1978, 52 days after the submission was received.
What is the product code of K780761?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.