Film Processor, Automatic
FDA 510(k) K770783 · General Electric Co.
510(k) numberK770783
Submission
- Device name
- Film Processor, Automatic
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- May 2, 1977
- Decision date
- May 10, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992896 | DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)EGY · Traditional | Dental X-Ray Support Systems, Inc. | 09/03/1999SE |
| K955825 | Smith S-100 Time & Temperature ControlEGY · Traditional | Smith Companies Dental Products | 04/05/1996SE |
| K955643 | Alara Imaging SystemEGY · Traditional | Denoptix, Inc. | 03/01/1996SE |
| K945682 | Processor, Radiographic-Film, Automatic, DentalEGY · Traditional | Gendex Corp. | 02/09/1995SE |
| K900156 | AP201 Dental X-Ray Film ProcessorEGY · Traditional | Allied Photo Products Co., Inc. | 05/14/1990SE |
| K874118 | Model 410 Dental X-Ray Film ProcessorsEGY · Traditional | Dent-X Co. | 11/06/1987SE |
| K811211 | Yoshida Ap 100EGY · Traditional | Kaycor Intl., Ltd. | 06/16/1981SE |
| K771433 | Auto. Devel. Unit Foo Dental X-RayEGY · Traditional | Ada Products Co., Inc. | 08/19/1977SE |
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Questions and answers
When was Film Processor, Automatic cleared by the FDA?
Film Processor, Automatic (K770783) received a 510(k) decision of Substantially Equivalent on May 10, 1977, 8 days after the submission was received.
What is the product code of K770783?
The FDA product code is EGY – Processor, Radiographic-Film, Automatic, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1900.