HEADSTRAP
FDA 510(k) clearance K854537 · decided 1985-12-03
Clearance details
- K-number
- K854537
- Device name
- HEADSTRAP
- Applicant
- Life Design Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-13
- Decision date
- 1985-12-03
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- BTK
- Device class
- 1
- Regulation number
- 868.5560
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GENERAL ANESTHESIA SYSTEM (K944949) | Vital Signs, Inc. | 1994-11-14 |
| STRAP, HEAD, GAS MASK (K914335) | Vital Signs, Inc. | 1992-04-02 |
| MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573) | Medipart Jerry Alexander | 1985-10-29 |
| HEAD STRAP (K831008) | Medovations, Inc. | 1983-05-09 |
| HEADSTRAP (K810991) | Respironics, Inc. | 1981-04-29 |
Recalls involving this device
No recalls on record reference this clearance.