Adam Shell Thermocouple Assembly
FDA 510(k) K944175 · Pro-Tech Services, Inc.
510(k) numberK944175
Submission
- Device name
- Adam Shell Thermocouple Assembly
- Applicant
- Pro-Tech Services, Inc.
Woodinville, WA, US - Received
- August 26, 1994
- Decision date
- October 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K972515 | Sensor AmplifierGWL · Traditional | 10/02/1997SE |
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Questions and answers
When was Adam Shell Thermocouple Assembly cleared by the FDA?
Adam Shell Thermocouple Assembly (K944175) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 49 days after the submission was received.
What is the product code of K944175?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.