Echo Cardiogram Pad
FDA 510(k) K791189 · Alimed, Inc.
510(k) numberK791189
Submission
- Device name
- Echo Cardiogram Pad
- Applicant
- Alimed, Inc.
Mchenry, IL, US - Received
- June 26, 1979
- Decision date
- July 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNJ – Bed, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5120
- Specialty
- General Hospital
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| K934298 | King KribFNJ · Traditional | Noritage, Inc. | 01/26/1994SE |
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | Warsaw Orthopedic, Inc. | 06/15/1989SE |
| K885241 | Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional | King Mfg. Co. | 02/24/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | Commercial Products & Engineering Co. | 11/21/1988SE |
| K881725 | Envirotent (Bed)FNJ · Traditional | Envirotents, Inc. | 11/08/1988SE |
| K881961 | Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional | Med Service, Inc. | 11/01/1988SE |
| K881964 | Msi 3003 Series BedFNJ · Traditional | Med Service, Inc. | 06/28/1988SE |
| K881962 | Msi 2005 Series BedFNJ · Traditional | Med Service, Inc. | 06/03/1988SE |
| K881043 | Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional | Junkin Safety Appliance Co., Inc. | 04/12/1988SE |
| K870166 | Platform Mattress W/Disposable Bedpan BagFNJ · Traditional | George C. Kuhn | 03/13/1987SE |
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| K963526 | Strap WedgeFMQ · Traditional | 10/28/1996SE |
| K920487 | Mini VibratorIRO · Traditional | 02/18/1992SE |
| K840156 | Protecta Coat SpongesIZZ · Traditional | 03/23/1984SE |
| K822650 | Super DonutKME · Traditional | 09/30/1982SE |
| K822651 | Total Finger Flexion SplintILH · Traditional | 09/17/1982SE |
| K820516 | Arterial Canalization DeviceDQY · Traditional | 04/15/1982SE |
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Questions and answers
When was Echo Cardiogram Pad cleared by the FDA?
Echo Cardiogram Pad (K791189) received a 510(k) decision of Substantially Equivalent on July 17, 1979, 21 days after the submission was received.
What is the product code of K791189?
The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.