Pymah Cold Sterilog Glutaraldehyde Monitor
FDA 510(k) K915170 · Pymah Corp.
510(k) numberK915170
Submission
- Device name
- Pymah Cold Sterilog Glutaraldehyde Monitor
- Applicant
- Pymah Corp.
Somerville, NJ, US - Received
- November 15, 1991
- Decision date
- July 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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| K934180 | Slimline 3000DXQ · Traditional | 11/24/1993SE |
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Questions and answers
When was Pymah Cold Sterilog Glutaraldehyde Monitor cleared by the FDA?
Pymah Cold Sterilog Glutaraldehyde Monitor (K915170) received a 510(k) decision of Substantially Equivalent on July 28, 1992, 256 days after the submission was received.
What is the product code of K915170?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.