Philips Pre-Filter Option
FDA 510(k) K923141 · Philips Medical Systems, Inc.
510(k) numberK923141
Submission
- Device name
- Philips Pre-Filter Option
- Applicant
- Philips Medical Systems, Inc.
5680 Da Best, NL - Received
- June 29, 1992
- Decision date
- January 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K920724 | High Speed Rotation Starter SA-50ITY · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
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Questions and answers
When was Philips Pre-Filter Option cleared by the FDA?
Philips Pre-Filter Option (K923141) received a 510(k) decision of Substantially Equivalent on January 21, 1993, 206 days after the submission was received.
What is the product code of K923141?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.