PTT-200 Pulmonary Receiver/Microproces
FDA 510(k) K812850 · Pharmaquest Corp.
510(k) numberK812850
Submission
- Device name
- PTT-200 Pulmonary Receiver/Microproces
- Applicant
- Pharmaquest Corp.
Mchenry, IL, US - Received
- October 9, 1981
- Decision date
- December 3, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K820248 | Rodder Volume VentilatorCBK · Traditional | 04/16/1982SE |
| K812849 | PTT-200 Telephonic Pulmonary TransmittBTY · Traditional | 12/03/1981SE |
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Questions and answers
When was PTT-200 Pulmonary Receiver/Microproces cleared by the FDA?
PTT-200 Pulmonary Receiver/Microproces (K812850) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 55 days after the submission was received.
What is the product code of K812850?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.