Mod. Mci 17 Manual Cuff Inflator
FDA 510(k) K800767 · Medasonics, Inc.
510(k) numberK800767
Submission
- Device name
- Mod. Mci 17 Manual Cuff Inflator
- Applicant
- Medasonics, Inc.
Mchenry, IL, US - Received
- April 7, 1980
- Decision date
- April 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
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|---|---|---|
| K991441 | Cadence Doppler Ultrasound SystemKNG · Traditional | 12/28/1999SE |
| K962796 | Neuroguard Transcranial Doppler Ultrasound SystemIYN · Traditional | 01/21/1997SE |
| K961116 | First Beat/Cardio Beat/CalcIYO · Traditional | 08/08/1996SE |
| K914862 | Cerebrovascular Diagnostic System; CDSIYN · Traditional | 12/03/1992SE |
| K911453 | Obtrasound Stethoscope Fetal CalcKNG · Traditional | 06/20/1991SE |
| K882018 | Medacord PVL, Personal Vascular LaboratoryJAF · Traditional | 09/21/1988SE |
| K872292 | Transpect Transcranial DopplerIYN · Traditional | 08/14/1987SE |
| K854734 | Model 5320 Ted Sequential Comp. De. Comp. Limb SleDRM · Traditional | 02/10/1986SE |
| K833588 | Vascular Laboratory Treadmill VT1IOL · Traditional | 11/14/1983SE |
| K837481 | BF24 Doppler Model P872 and P874 · Traditional | 06/24/1983SE |
Questions and answers
When was Mod. Mci 17 Manual Cuff Inflator cleared by the FDA?
Mod. Mci 17 Manual Cuff Inflator (K800767) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 17 days after the submission was received.
What is the product code of K800767?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.