Duraderm Butterfly
FDA 510(k) K881343 · Sentry Medical Products, Inc.
510(k) numberK881343
Submission
- Device name
- Duraderm Butterfly
- Applicant
- Sentry Medical Products, Inc.
Santa Ana, CA, US - Received
- March 30, 1988
- Decision date
- May 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | 08/30/1994SE |
| K935098 | Baby BoardBTX · Traditional | 02/15/1994SE |
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| K932704 | Patient CableDSA · Traditional | 12/27/1993SE |
| K881670 | Accutemp PlusFMT · Traditional | 11/22/1988SE |
| K851522 | Diagnostic ECG Disposable ElectrodeDRX · Traditional | 10/24/1985SE |
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Questions and answers
When was Duraderm Butterfly cleared by the FDA?
Duraderm Butterfly (K881343) received a 510(k) decision of Substantially Equivalent on May 4, 1988, 35 days after the submission was received.
What is the product code of K881343?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.