Gaeltec MPR Series
FDA 510(k) K921062 · Medical Measurements, Inc.
510(k) numberK921062
Submission
- Device name
- Gaeltec MPR Series
- Applicant
- Medical Measurements, Inc.
Hackensack, NJ, US - Received
- March 5, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K902097 | Model TR Rectal Suction Biopsy TubeFCK · Traditional | 07/27/1990SE |
| K863479 | Modified Ict/B Intracranial Press. Trans. EpiduralGWM · Traditional | 10/14/1986SE |
| K801757 | Mmi/Gaeltec Catheter Tip Press. TransduFES · Traditional | 08/27/1980SE |
| K801756 | Mmi/Gaeltec Catheter Tip TransducDXO · Traditional | 08/20/1980SE |
| K801880 | Mmi/Gaeltec Series 8T Diff. Press. TransBYR · Traditional | 08/14/1980SE |
| K801758 | Mmi/Gaeltec Catheter IntrauterineKXO · Traditional | 08/14/1980SE |
| K801755 | Mmi/Gaeltec Catheter Tip PressureGWM · Traditional | 08/13/1980SE |
Questions and answers
When was Gaeltec MPR Series cleared by the FDA?
Gaeltec MPR Series (K921062) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 147 days after the submission was received.
What is the product code of K921062?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.