BYG — Mask, Oxygen Class I
FDA product code BYG covers "Mask, Oxygen", a Class I medical device regulated under 21 CFR 868.5580. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYG
- Device Class
- Class I
- Regulation Number
- 868.5580
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K963298 | vector | FIRST AID KIT(S) | November 6, 1996 |
| K962848 | hans rudolph | HANS RUDOLPH NASAL CPAP MASK | October 16, 1996 |
| K945482 | fvtnks | DISPOSABLE, CPAP OXYGEN MASK | September 19, 1995 |
| K953464 | westmed | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | September 18, 1995 |
| K953039 | dadsun corp | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | September 15, 1995 |
| K945472 | westmed intl | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | February 7, 1995 |
| K942907 | respan products | JEMSDAL MASK | August 31, 1994 |
| K940887 | medic-aid | SYSTEM 22 ADULT MASK | April 19, 1994 |
| K940888 | medic-aid | SYSTEM 22 PAEDIATRIC MASK | April 19, 1994 |
| K931952 | medway | MEDWAY OXYGEN MASK | August 20, 1993 |
| K924069 | gujarat surgico | SURGICO OXYGEN MASK | February 4, 1993 |
| K921499 | devilbiss health care | SEAL RING FOR NASAL CPAP | September 17, 1992 |
| K913501 | b and f medical products | TRACHEOSTOMY MASK | January 13, 1992 |
| K913383 | specialty packaging producs | OXYGEN MASKS 81420, 81421, 81471 & 81461 | October 18, 1991 |
| K913275 | specialty packaging producs | VENTURI OXYGEN MASK | October 10, 1991 |
| K913455 | specialty packaging producs | OXYGEN MASKS 82400 & 82405 | October 2, 1991 |
| K912633 | salter labs | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | July 19, 1991 |
| K905288 | med-tek innovations | ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES | April 9, 1991 |
| K904719 | tri/bor medical | DISPOSABLE FACE MASK | January 2, 1991 |
| K904195 | bp | DISPOSABLE FACE MASK | September 25, 1990 |