Head Strap
FDA 510(k) K831008 · Medovations, Inc.
510(k) numberK831008
Submission
- Device name
- Head Strap
- Applicant
- Medovations, Inc.
Mchenry, IL, US - Received
- March 30, 1983
- Decision date
- May 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTK – Strap, Head, Gas Mask
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5560
- Specialty
- Anesthesiology
Other 510(k)s with product code BTK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944949 | General Anesthesia SystemBTK · Traditional | Vital Signs, Inc. | 11/14/1994SESK |
| K914335 | Strap, Head, Gas MaskBTK · Traditional | Vital Signs, Inc. | 04/02/1992SE |
| K854537 | HeadstrapBTK · Traditional | Life Design Systems, Inc. | 12/03/1985SE |
| K853573 | Medipart Face Mask Headstrap MP-9100BTK · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K810991 | HeadstrapBTK · Traditional | Respironics, Inc. | 04/29/1981SE |
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| K002363 | Medovations Esophageal DilatorKNQ · Traditional | 11/01/2000SE |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | 02/02/1998SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
Questions and answers
When was Head Strap cleared by the FDA?
Head Strap (K831008) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 40 days after the submission was received.
What is the product code of K831008?
The FDA product code is BTK – Strap, Head, Gas Mask, a Class I (low risk) device regulated under 21 CFR 868.5560.