Strap, Head, Gas Mask
FDA 510(k) K914335 · Vital Signs, Inc.
510(k) numberK914335
Submission
- Device name
- Strap, Head, Gas Mask
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- September 27, 1991
- Decision date
- April 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K854537 | HeadstrapBTK · Traditional | Life Design Systems, Inc. | 12/03/1985SE |
| K853573 | Medipart Face Mask Headstrap MP-9100BTK · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K831008 | Head StrapBTK · Traditional | Medovations, Inc. | 05/09/1983SE |
| K810991 | HeadstrapBTK · Traditional | Respironics, Inc. | 04/29/1981SE |
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Questions and answers
When was Strap, Head, Gas Mask cleared by the FDA?
Strap, Head, Gas Mask (K914335) received a 510(k) decision of Substantially Equivalent on April 2, 1992, 188 days after the submission was received.
What is the product code of K914335?
The FDA product code is BTK – Strap, Head, Gas Mask, a Class I (low risk) device regulated under 21 CFR 868.5560.