Bera SH 221 Brian Stem Audiometer
FDA 510(k) K830173 · Jedmed Instrument Co.
510(k) numberK830173
Submission
- Device name
- Bera SH 221 Brian Stem Audiometer
- Applicant
- Jedmed Instrument Co.
Mchenry, IL, US - Received
- January 18, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNJ – Antigens, Ha, Echovirus 1-34
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3205
- Specialty
- Microbiology
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Questions and answers
When was Bera SH 221 Brian Stem Audiometer cleared by the FDA?
Bera SH 221 Brian Stem Audiometer (K830173) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 127 days after the submission was received.
What is the product code of K830173?
The FDA product code is GNJ – Antigens, Ha, Echovirus 1-34, a Class I (low risk) device regulated under 21 CFR 866.3205.