510(k) K810991
- Device
- Headstrap
- Applicant
- RESPIRONICS, INC.
- 510(k) number
- K810991
- Product code
- BTK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-29
- Date received
- 1981-04-13
- Regulation
- 868.5560
- Classification name
- Strap, Head, Gas Mask
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 530 Seco Rd. Monroeville PA US 15146 15146
FDA Registration Numbers#
- 3007697981
- 3003898360
- 2032476
- 8010042
- 3006547005
- 2023529
- 3008770063
- 3016674860
- 3036979319
- 3011237770
- 3010834934
- 3006395447
- 2529776
- 3010394125
- 3015134079
- 3018783526
- 3001650535
- 3009171251
- 1928237
- 8021995
- 3016710298
- 3022777869
- 9611500
- 9680215
- 1832562
- 3012017650
- 3021244152
- 3010402691
- 3009512503
- 3010703418
- 3006446479
- 3003862188
- 3012262567
- 3008603863
- 3013152643
- 9615543
- 3009240152
- 3010386003
- 3003902679
- 8022779
- 3005012805
- 1722095
- 3004365956
- 3004604967
- 3007309299
- 1220908
- 3006621348
- 3003902312
- 3029871637
- 3011529836
- 1836161
- 3023272766
- 3042750388
- 3012316249
- 3006783791
- 3008058406
- 2518422
- 8010939
- 3013909820
- 9710567
- 3008808560
- 3007222552
- 3030220356
- 3006061749
- 2032273
- 3014624980
- 9710641
- 3012494290
- 3000126629
- 3042251637
- 1924066
- 3024821684
- 3008381116
- 3000143502
- 3006563173
- 3011706862
- 3003855936
- 3043620709
- 3007028032
- 8020785
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BTK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944949 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | 1994-11-14 |
| K914335 | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | 1992-04-02 |
| K854537 | HEADSTRAP | Life Design Systems, Inc. | 1985-12-03 |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | 1985-10-29 |
| K831008 | HEAD STRAP | Medovations, Inc. | 1983-05-09 |