Pfizer Pz-Slm Rad. Therapy Trtmt. Simul.
FDA 510(k) K803032 · Pfizer Medical Systems, Inc.
510(k) numberK803032
Submission
- Device name
- Pfizer Pz-Slm Rad. Therapy Trtmt. Simul.
- Applicant
- Pfizer Medical Systems, Inc.
Mchenry, IL, US - Received
- December 1, 1980
- Decision date
- January 22, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Nucletron Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K802532 | Pfizonic 300 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802531 | Pfizonic 200 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802530 | Pfizonic 250 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802529 | Pfizonic 100 Ultrasound ScannerDXK · Traditional | 12/18/1980SE |
| K802528 | Pfizonic 150 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K801446 | Pfizer Pz-Ct ScannerJAK · Traditional | 07/28/1980SE |
| K800501 | Pfizer/As&E 0450 LocalizerJDX · Traditional | 04/10/1980SE |
| K781752 | Scanner, CT 0450JAK · Traditional | 11/03/1978SE |
| K780278 | Radiation Therapy Treat. Plan. Sys.JAD · Traditional | 03/02/1978SE |
| K772289 | Scanner, CT, 0400JAK · Traditional | 12/21/1977SE |
Questions and answers
When was Pfizer Pz-Slm Rad. Therapy Trtmt. Simul. cleared by the FDA?
Pfizer Pz-Slm Rad. Therapy Trtmt. Simul. (K803032) received a 510(k) decision of Substantially Equivalent on January 22, 1981, 52 days after the submission was received.
What is the product code of K803032?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.