Face Tents
FDA 510(k) K781055 · Hospitak, Inc.
510(k) numberK781055
Submission
- Device name
- Face Tents
- Applicant
- Hospitak, Inc.
Mchenry, IL, US - Received
- June 23, 1978
- Decision date
- July 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYG – Mask, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5580
- Specialty
- Anesthesiology
Other 510(k)s with product code BYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963298 | First Aid Kit(S)BYG · Traditional | Vector, Inc. | 11/06/1996SE |
| K962848 | Hans Rudolph Nasal CPAP MaskBYG · Traditional | Hans Rudolph, Inc. | 10/16/1996SE |
| K945482 | Disposable, CPAP Oxygen MaskBYG · Traditional | Fvtnks | 09/19/1995SE |
| K953464 | Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional | Westmed, Inc. | 09/18/1995SE |
| K953039 | Various Adult & Child High Con/Nonrebreath Oxy MasksBYG · Traditional | Dadsun Corp., Ltd. | 09/15/1995SE |
| K945472 | Westmed Pediatric and Adult Aerosol MaskBYG · Traditional | Westmed Intl. | 02/07/1995SE |
| K942907 | Jemsdal MaskBYG · Traditional | Respan Products, Inc. | 08/31/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K940887 | System 22 Adult MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K931952 | Medway Oxygen MaskBYG · Traditional | Medway | 08/20/1993SE |
More from Medway
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
Questions and answers
When was Face Tents cleared by the FDA?
Face Tents (K781055) received a 510(k) decision of Substantially Equivalent on July 17, 1978, 24 days after the submission was received.
What is the product code of K781055?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.