Meter, IV PH, Model Expandomatic
FDA 510(k) K770352 · Beckman Instruments, Inc.
510(k) numberK770352
Submission
- Device name
- Meter, IV PH, Model Expandomatic
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- February 22, 1977
- Decision date
- April 8, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQY – Ph Meter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952178 | Ph-Detect TestJQY · Traditional | Diagnostic Reagents, Inc. | 10/20/1995SE |
| K905146 | Olympus Urine PHJQY · Traditional | Diagnostic Systems | 02/04/1991SE |
| K872888 | Ciba Corning 288 Ph/Blood Gas SystemJQY · Traditional | Ciba Corning Diagnostics Corp. | 08/25/1987SE |
| K770347 | Meter, PH, Digital, Model 3560JQY · Traditional | Beckman Instruments, Inc. | 04/15/1977SE |
| K770351 | Meter, IV PH, Model ZeromaticJQY · Traditional | Beckman Instruments, Inc. | 04/05/1977SE |
| K760789 | PH METER-130 (.001 PH)JQY · Traditional | Corning Medical & Scientific | 11/16/1976SE |
| K760788 | PH METER-125 (.01 PH)JQY · Traditional | Corning Medical & Scientific | 11/16/1976SE |
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Questions and answers
When was Meter, IV PH, Model Expandomatic cleared by the FDA?
Meter, IV PH, Model Expandomatic (K770352) received a 510(k) decision of Substantially Equivalent on April 8, 1977, 45 days after the submission was received.
What is the product code of K770352?
The FDA product code is JQY – Ph Meter, a Class I (low risk) device regulated under 21 CFR 862.2050.