Pfizer/As&E 0450 Localizer
FDA 510(k) K800501 · Pfizer Medical Systems, Inc.
510(k) numberK800501
Submission
- Device name
- Pfizer/As&E 0450 Localizer
- Applicant
- Pfizer Medical Systems, Inc.
Mchenry, IL, US - Received
- March 4, 1980
- Decision date
- April 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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More from Sra Developments, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K803032 | Pfizer Pz-Slm Rad. Therapy Trtmt. Simul.KPQ · Traditional | 01/22/1981SE |
| 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 |
| 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/As&E 0450 Localizer cleared by the FDA?
Pfizer/As&E 0450 Localizer (K800501) received a 510(k) decision of Substantially Equivalent on April 10, 1980, 37 days after the submission was received.
What is the product code of K800501?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.